Roche Diagnostics Operations, Inc. Recalls
Showing 21-40 of 76 recalls
cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.
On 1/7/2020, the firm distributed Urgent Medical Device Correction letters to affected consignees. Customers were asked to do the following: " Be aware of the incorrect display of the alarm flags on the cobas infinity Validation screen if an alarm has a < symbol in front of it and if doing manual validations. " It is not recommended to use the alarm mapping function on the cobas infinity until your system is patched. If your laboratory does use it, please call the Roche Support Network Customer Support Center at 1-800-526-2272 for further information. " Complete the customer response form and return it to the recalling firm. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272 if you have questions about the information contained in this UMDC.
Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001
Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver - Incorrect Alarm Mapping
Roche issued Urgent Medical Device Correction TP-00791 mailed via UPS Ground (receipt required) on 10/8/2019. The letter identifies the problem, health risk and action to take: Complete the attached fax form (TP-00792) and fax or email it according to the instructions on the form. " File this Urgent Medical Device Correction (UMDC) for future reference Roche will resolve this issue in a future software update. In the next couple of weeks, a Roche Representative will be contacting you to adjust alarm code mapping as needed per your specific configuration. Contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-526-2272 if you have questions. The UMDC will also post to the diagnostics.roche.com website
Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems Catalog Number: 06542921190 - - Product Usage: The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria.
Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
The Urgent Medical Device Correction (UMDC) was sent via Roche issued Urgent Medical Device notification via FedEx (signature required) to the consignee list on 10/04/2019. The letter states issue, health risk nd action to take: Discontinue use and discard the remaining affected product in inventory according to local waste guidelines. Because a replacement lot is currently not available, Roche will issue credit for Homocysteine cobas c packs, lot number 422313, remaining in your inventory. If customers have another validated system (i.e. cobas c501/502) in their lab and wish to set up the Roche Homocysteine assay on one of these modules (different catalog number than that subject to this recall), they will be instructed to contact a Roche Field Specialist for support. " A reimbursement for send out testing to an accredited laboratory will also be provided for those customers without another Roche system available. Contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information The UMDC will also be posted to the diagnostics.roche.com website.
BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket
Roche issued Urgent Medical Device Correction letter on 8/31/20 via UPS Ground Receipt stating: reason for recall, health risk and action to take: actions below. " Inform any operators that use the BenchMark ULTRA and DISCOVERY ULTRA instruments of the potential hazards associated with this issue and provide a copy of this notification as appropriate. " Inspect the instrument daily for evidence of leaks (i.e., liquid outside of the waste reservoir, liquid on the floor, liquid on the skin/outer panel of the instrument). " If you experience a fluid leak, stop using the system and turn off the power to the instrument. Immediately contact the Roche Support Network Customer Support Center at 1-800-227-2155. " Complete the attached fax back form (TP-01057) and fax or email it according to the instructions on the form. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. " File this UMDC for future reference Local Field Engineering Specialists (FESs) will perform specific service actions, including the completion of the Waste Tub and Filter Upgrade (if it has not already been implemented), inspection of specific instrument parts for signs of cracks and fluid leaks, and installation of a power connector shield, which will prevent fluid entry into the power cord connection and socket. Contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-227-2155 if you have questions about the information contained in this UMDC.
cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122
Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference
Roche issued notification to consignees by Urgent Medical Device Correction (TP-00754) sent via UPS (signature required) on 8/28/19. The UMDC will also be available on diagnostics.roche.com. The letter identifies the problem, risk to health and action to take: Be aware of new interference claims that are listed in this UMDC and that the rhEPO Therapy Monitoring Statement will be removed from the Method Sheets. The UMDC will serve as intermediate labeling until the updated method sheets are available. Complete all sections of the enclosed fax form. Contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions if you have questions
cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
Quality issue with high pressure solenoid valves may cause inaccurate results.
1. For the cobas 8000 ISE, cobas c 701, and cobas c 702 modules and the cobas c 513 analyzer, stop using these units immediately. Your FES will be in contact with you to replace these affected high pressure solenoid valves immediately. 2. In the event that the high pressure solenoid valves cannot be replaced immediately, for the cobas e 601 module, follow the wash station checks outlined in this Urgent Medical Device Correction (UMDC). Perform these checks once per shift. If these checks show favorable outcomes and quality control results are within range, patient results may be reported. If these checks produce unfavorable outcomes, stop using your cobas e 601 module and call the Roche Support Network Customer Support Center at 1-800-428-2336. 3. Complete the attached fax form and fax or email it according to the instructions on the form. 4. File this Urgent Medical Device Correction (UMDC) for future reference Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.
Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
Inaccurately Low Sample Results
1. Consignees will be provided instruction to download the updated e-barcode either from the cobas link or from the cobas e-library when available. 2. If analyzers cobas link is not connected to the Roche network, a future version of the cobas e-library CD will contain the revised e-barcodes. Download the e-barcode when available. 3. If analyzers cobas link is not connected to the Roche network and they require the updated VANC3 application e-barcode before the cobas e-library CD is available, they will be instructed to contact the Roche Support Network Customer Support Center at 1-800-428-2336 to request a Field Application Specialist to provide the VANC3 updated application. 4. Calibrate and run quality controls (QC) before running samples. 5.Complete all sections of the enclosed fax form. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.
cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not correctly placed back in the Rack Tube Transport (RTT) after the decapping process. Therefore, open sample tubes can be dropped in the cobas p 512, spilling the sample material.
Roche Diagnostics sent an "Urgent Medical Device Correction" letter via UPS Ground (receipt required) on February 23, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. To prevent this malfunction, a software patch has been developed and validated. The installation of this software patch is mandatory and will be performed by a Roche Field Engineering Specialist (FES). Your Roche FES will contact you to schedule the installation of the software patch. Until the software patch is implemented, Roche recommends that instrument operators monitor their systems for the occurrence of Error 140 Gripper has lost tube. If this error occurs, all components in contact with a spill must have extra cleaning. Refer to the cobas p 512 pre-analytical instrument Operators Manual Version 1.5. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 for further questions.
Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.
The Initial Cassette Volume Check (ICVC) is not activated on the cobas c 502 module of the cobas 8000 modular analyzer series when manually filled cobas c packs are loaded. This issue occurs with tests that use cobas c pack MULTI or empty pre-labeled cobas c packs. The ICVC feature allows the reagent probe to dive into the reagent cassette and confirm the reagent level in the bottles. This ensures
March 17, 2014 all consignees will be notified by Urgent Medical Device Correction sent via UPS Ground (receipt required). The notice identified the issue, root cause, affected assays with clinical significance. Consignees were instructed to follow the steps listed in the Urgent Medical Device Correction to correctly activate the ICVC and verify the correction. If your system is not connected to the Internet through the cobas link, and you do not have the option to run the affected reagents on an alternate system (i.e., cobas c 311 or cobas c 501 analyzer), please contact the Roche Support Network Customer Support Center at 1-800-428-2336 to have an update scheduled via a Roche Field Representative. If your system is connected to the Internet through the cobas link, follow the steps below: " Remove all reagent cobas c packs on board your cobas c 502 module for the assays listed on pages 1-2. " Dispose of these reagent cobas c packs according to your local waste management ordinances. " Load new cobas c packs for the affected assays, and visually verify the ICVC is performed. " Complete the attached fax form (5326-00-0314) and fax it to 1-888-276-6166. " Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. " File this Urgent Medical Device Correction (UMDC) for future reference.
Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.
The default references for normal values are inconsistent between cobas b 221 and other blood gas instruments. In addition, the reference ranges are different when comparing with corresponding ranges listed in the Instructions for Use for the analyzer and the reference literature source.
The Urgent Medical Device Correction will be sent via UPS Ground (receipt required) to the consignee list. The Urgent Medical Device Correction will be sent via UPS Ground (receipt required) to the consignee list. Consignees are instructed as follows: " Check the current set of reference values on your cobas b 221 blood gas system and, if appropriate, change the reference ranges accordingly. " If you have not established your own reference ranges, please follow the instructions in the Workaround section of the UMDC or contact the Roche Support Network Customer Support Center.
ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).
Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards.
Consignees of both devices were notified by Urgent Medical Device Correction letters sent via UPS Ground (receipt required) beginning 3/06/2013. The notice contained recommendation not to use EAN-13 barcode system and ensure barcodes used meet quality standards; use operator and patient lists (downloaded from a data manager) in order to check any decoded identification against the respective list. The notice directed forwarding of the notice if the product was further distributed. Customers were asked to complete the attached fax form. Contact the Customer Care Service Center, 24 hours a day, seven days a week at 1-800-440-3638 for Accu check questions and 1-800-428-4674 for CoaguChek questions about the information contained in this UMDC.
Estradiol III; Elecsys and cobas e analyzers; REF 06656021 190; M 6.5 mL, R1 9 mL, R2 9 mL, For USA: CONTENT M Streptavidin-coated microparticles 0.72 mg/ml; R1 Two biotinylated monoclonal anti-estradiol antibodies (rabbit) 2.5 ng/m and 4.5 ng/mL Mesterolone 130 ng/mL; R2 Estradiol derivative, labeled with ruthenium complex 4.5 ng/mL; Rx only Product Usage: Immunoassay for the in vitro quantitative determination of estradiol in human serum and plasma. The electrochemiluminescence immunoassay
Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not be used when monitoring patient being treated with fulvestrant. Customers should be informed that fulvestrant will increase the apparent concentration of estradiol in women being treated with this drug. If treatment with fulvestrant has been altered or discontinued as a result of falsely elevated e
Roche sent an Urgent Medical Device Correction letter dated March 7, 2016 via UPS Ground (receipt required) to the consignee list. The letter identified the affected product, problem and actions to be taken. Consignees were instructed to complete the attached fax form and fax it to 1-866-891-1984. For questions contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336.
Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following systems: 1. 03337103001, cobas b 221<1>Roche OMNI S1 system 2. 03337111001, cobas b 221<2>Roche OMNI S2 system 3. 03337154001,cobas b 221<6>Roche OMNI S6 system 4. 03337138001, cobas b 221<4>Roche OMNI S4 system Product Usage: Usage: Blood Gas and Electrolytes Analyzer c. Classification Name: Fully automated Critical Care Analyzer for the measurement of pH, Bl
Reference electrode used beyond the guaranteed in-use 52 week lifetime,may leak and potentially cause erroneous pH and/or sodium results. Other Ion parameters are not affected.
Roche Diagnostics Operations sent an Urgent Medical Device Correction letter dated February 27, 2014 via UPS Ground (receipt required) to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the enclosed fax form and fax it to 1-888-345-0253. For questions contact Roche Customer Business Support Center at 1-800-428-5076.
ACCU-CHEK Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be det
Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on the ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets. If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify
Roche sent the "Urgent Medical Device Corrections" letter dated 12/1/2014 via UPS Ground (receipt required) to the Patients, and Distributors who received the affected device. The letter included a description of the reason for recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. No product returns were expected. For questions, contact the ACCU-CHEK Pump Support at 1-800-688-4578.
ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is meant only for single-patient use; the device may not be used for screening or diagnosis of diabetes or for multiple patient use. It is indicated for the treatment of insulin requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger. The ACCU-CHEK Spirit Combo Insulin Pump is intended for the subcutaneous continu
The insulin pump may lose time and date settings during a power interruption (such as a battery change) due to a faulty capacitor. If the capacitor fails, the time and date will return to default setting. Though the pump prompts customers to confirm the time and date, if the user does not recognize the time and date have returned to default, a shift of their basal rate time block could occur.
Roche sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated September 25, 2014 via UPS Ground (receipt required) to the consignees. The letter included a description of the reason for recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. No product returns were expected. For questions, contact the ACCU-CHEK Customer Care Service Center at 1-800-688-4578.
MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutio
Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be detected by QC. QC measurement results can be affected as well. This issue is only detectable if comparison result of a second measurement is available. The cause for this issue is an error in the software measurement procedure. In children, decreased urea results can point at inborn disorders or urea cycle. Therefore, false normal urea values could lead to delayed/incorrect diagnosis of such a disorder. Besides the patients most at risk, the risk for the overall patient population with falsely low or high values is considered remote. No severe adverse health effects are expected; but, unnecessary diagnostic measures may be initiated. Falsely normal results may result in further necessary examination not being carried out, with the possibility of a delay in the diagnosis and treatment. A medical risk cannot entirely be excluded.
Roche sent an Urgent Medical Correction letter dated October 31, 2016, to all affected customers. The recall notifications included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Actions Required " Use the workaround outlined in this Urgent Medical Device Correction (UMDC) for Urea measurement until the updated software version is available. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. " Complete the attached fax form and fax it to 1-877-766-7471. " File this UMDC for future reference. Questions Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272 if you have questions about the information contained in this UMDC.
Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride.
cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20 may encounter the following alarm: 7002: 108000572, A software error occurred. This alarm is generated due to a measurement timing error. Under very rare conditions, the instrument may process two tests in the same cuvette if the run restarts. If a used cuvette is used again result of the test(s) will be erroneous. These erroneous results may not be flagged. Falsely low or high patient results may lead to incorrect diagnostic measures and medical therapeutic decisions. The medical risk depends on the parameter.
Roche sent an URGENT MEDICAL DEVICE CORRECTION letter dated September 27, 2016 to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were asked to complete the attached fax form and fax it to 1-866-808-1159. For questions contact the Roche Support Network Customer Support Center at 1-800-428-2336.
Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640190
Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quant Hemoglobin A1c Gen.2 and Tina-quant Hemoglobin A1cDx Gen.2 cassettes/bottles. This issue occurred over multiple lots. Single cassettes/bottles of the reagents are affected. The issue can lead to erroneously high HbA1c results. If a patient with known diabetes is affected, an erroneously high HbA1c result might lead to therapeutic consequences, such as therapy escalation (introduction of another oral antidiabetic medication or insulin) or increase of the dosage. This can further lead to an increased risk of hypoglycemia. Considering the unreliable detectability of the issue, relevant medical risk for the patient cannot entirely be excluded.
On 10/4/2016, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected Direct Consignees and Distributors via courier. The recall notifications included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Direct Consignee Actions Required " Follow the instructions in the Customer Actions for Prevention/Detection of the Issue section of this Urgent Medical Device Correction (UMDC). " Complete the attached fax form (7184-00-1016) and fax it to 1-844-294-7181. " File this Urgent Medical Device Correction (UMDC) for future reference. Questions Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC. Distributor Actions Required " Ensure proper storage conditions (2-8C) are maintained for the reagents listed in the table above, per their respective method sheet. " If you have not directly shipped any of the products in the table above, you do not need to distribute the enclosed UMDC to your customers. " If you have directly shipped any of the products in the table above, please distribute the enclosed UMDC 16-157 to those customers. " Complete the attached fax form (7185-00-1016) and fax it to 1-844-294-7181. Questions Please contact the Roche Support Network Customer Support Center at 1-800-428-2336 if you have questions about the information contained in this distributor letter or the enclosed UMDC 16-157.
Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COT~b, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory. The integrated AutoQC module and
under specific settings, an issue may occur during simultaneous Sensor Cartridge and Fluid Pack change on the cobas b 123 <2> POC system and cobas b 123 <4> POC system. The issue occurs when the software function [AutoQC as follow-up] is configured to run all three levels of AutoQC only after a Fluid Pack change, but not after a Sensor Cartridge change. When both are changed simultaneously, starting with the Sensor Cartridge and followed by the Fluid Pack, the analyzer carries out only the follow-up actions associated with the Sensor Cartridge change after completing the change workflow. As a result, no follow-up AutoQC is performed and the three expected AutoQC measurements for the Fluid Pack change are not carried out. Without running quality control, there is a remote possibility that system issues would not be detected and wrong results would not be excluded on all parameters: pH, PO2, PCO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, SO2, O2Hb, COHb, MetHb, HHb, and Bili.
Roche issued an Analyzer Bulletin on September 3, 2015, to all affected Consignees. The recall notifications included a description of the reason for the recall, affected product, and consignee responsibilities; the notification did not include instructions for responding to the notification. Actions Required " Follow the workaround outlined in this Analyzer Bulletin to avoid the described issue. " File this Analyzer Bulletin for future reference. Questions Please contact the Roche Support Network Customer Support Center at 1-800-526-2272 if you have questions about the information contained in this Analyzer Bulletin.
Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use. Modular E170: Immunoassay Analyzer Product Usage: The Roche COBAS INTEGRA 800/800 CTS Analyzer is fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
On 7/15/2016, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, an updated cleaning procedure, and instructions for responding to the formal recall notification. Please contact the Roche Support Network Customer Support Center at 1-800-428-2336 if you have questions about the information contained in this UMDC. On 10/5/2016, URGENT MEDICAL DEVICE CORRECTION UPDATE notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The notification updated the 7/15/16 notification to include additional affected systems and to provide updated cleaning instructions for all systems via the enclosed Operators Manual addendum.