Radiometer America Inc Recalls

Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and ABL837. ABL800 Series Ref. 393-803, 393-804, 393-805, 393-806, 393-820, 393-821, 393-825, 393-826, 393-835, 393-836, 393-844, 393-845.

From three incidents in Denmark and Sweden, comparison studies on patient blood samples carried out for quality assurance demonstrated that creatinine measurements as determined on analyzers could be underestimated with up to 28% as compared with measurements from COBAS. The underestimated creatinine occurs specifically, when measurements on Autocheck 6+ level 1 (also known as S7835 Autocheck module and abbreviated AC6+L1) are less than or equal to 230 micro-meter of a specified insert interval for AC6+L1 with insert limits 210 290 micro-meter. Ultimately, a lower read-out on patient samples is observed Customers are concerned about underestimation of creatinine results in patients, which are to undergo radiocontrast x-ray investigations. If these patients are not healthy, the exposure of radiocontrast agents may induce kidney insufficiency (contrast-induced nephropathy). Hazardous situation: Underestimation of the concentration of creatinine.

On 07/06/2018, the firm sent a Priority Level: Recall Letter to customers via Federal Express Courier Service informing them that the firm has recently become aware that the ABL800 FLEX analyzer can potentially report lower than expected cCrea results on patient samples. The difference has been reported to be as high as -28%. The issue may not be caught by running QC, as the QC will be lower, but still within range. Risk for the patient The described error may potentially lead to an underestimation of the actual serum creatinine concentration (cCrea) of up to 28% or erroneous measurement values for cCrea, resulting in no detection of renal insufficiency or underestimation of moderate to severe renal failure. In case of a non-detected minor renal insufficiency, the patient may be subjected to diagnostic imaging procedures involving intravenous injection of contrast, which may, in a worst-case scenario, lead to acute renal failure (contrast-induced nephropathy, CIN). Affected product: All ABL800 FLEX analyzers measuring cCrea. Interim Countermeasure Before reporting cCrea results, verify the performance of the membrane units as described below: -If not already installed, install S7835 Autocheck 6+. Level 1 (#944-094) -Manually adjust the cCrea lower limit for S7835 AutoCheck 6+, level 1 by +20 mol/L (example: Adjust from 210 mol/L to 230 mol/L). You must do this for every lot of QC ampoules used for the verification. -Perform one quality control measurement using S7835 AutoCheck 6+, level 1 on already installed Crea membrane units to verify the cCrea performance. If the QC result is out of range, install new Crea A and Crea B membranes. Until further notice, follow the procedure every 24 hours and upon replacement of Crea A and Crea B membranes: -Perform one quality control measurement using S7835 AutoCheck 6+, level 1, to verify the cCrea performance. -If the QC result is out of range, install new Crea A and Crea B membranes The abov

ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) - in vitro testing of samples of expired air for the parameters pO2 and pCO2. It is also used for in vitro testing of pleura samples for the pH parameter

Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient will be printed or displayed on the analyzer.

Customer were notified via letter using FedEx tracking on approximately October 24, 2017. Instructions included verification that the test results and the patient and demographic information matches, that Radiometer America is working to improve the software to remove the possibility of the code being misinterpreted, and to notify customers if the product has been further distributed. For further questions, please call (800) 736-0600.

ABL800 analyzer, model numbers 393-800 and 393-801.

The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.

The recalling firm issued letters dated 7/3/2018 on 7/3/2018 via FedEx.

ABL90 FLEX Analyzer REF 393090 UDI:05700693930909

Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment.

On (date), the firm will email a "Urgent Field Safety Notice" to all customers and will follow-up by mailing a copy of the "Urgent Field Safety Notice" to all customers via Federal Express with tracking and proof of delivery. The Urgent Field Safety Notice ask customers to do the following: 1. Check which version of the operating system (OS) is currently installed on your analyzer: o Logon to the analyzer o Touch Menu, Utilities, Temporary shutdown, and then Confirm o During the shutdown process the analyzer displays the version of OS installed " If the OS version is one of the following your analyzer is affected by the vulnerability: RXPE - UIM2743 v1.3.xxxxxx or RXPE-UIM910v1.3.xxxxxx 2. If your analyzer is found to be affected by the vulnerability the following options must be applied: Short term: If your analyzer is connected to a network and your IT department assesses that the Hospital Firewall and Network settings prevent a remote attacker from connecting to the analyzer to exploit the vulnerability, you may decide to keep the analyzer connected. Otherwise, we recommend disconnecting it until one of the long term countermeasures below has been implemented. Long term: Countermeasure 1: Contact your Radiometer representative to have the RXPE Security patch update installed on your analyzer. (Note: Microsoft does not support Windows XP anymore. However, Microsoft has extraordinarily released a patch for this particular vulnerability.) or Countermeasure 2: Contact your Radiometer representative to receive a quote for an upgrade to latest OS (Windows 7 embedded) from Radiometer, which is supported by Microsoft. 3.Please complete the Recall Response Form (last page of the customer advisory letter) and return it to your Radiometer representative. 4.Please Note: If you are not the end-user of the affected product, please ensure that this letter is distributed to the final end-users. If you have questions, please contact Radiometer

ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.

The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: The analyzer is in ready mode Operator lifts the inlet and then closes it again, thereby initiating a rinse Immediately after lifts the inlet and quickly closes it again

The firm, Radiometer America, Inc., notified customers via letter dated 05/25/2015. The letter provided the following: Reason for recall, Affect product description and codes, Risk for the patient, What customers must do, Countermeasure provided by Radiometer, contact information and Response Form. The customers were instructed to do the following: 1. Inform users of the ABL90 FLEX analyzer that the inlet is not to be repeatedly lifted and closed. If this does happen, the easiest way to reset the analyzer flow selector manually is to re-install the solution pack. Follow the procedure described in the IFU for installation of a solution pack. You may re-use the same solution pack. 2. We recommend that you review previous results, where cNa+ and cCl- results are off from the expected results with the values found in table 1. 3. Complete the recall response fax form (last page of this customer advisory letter) and submit to your Radiometer representative via Fax to:714 582 0806. If you have any questions, please contact your Radiometer representative or Quality Assurance/ Regulatory Affairs Manager at 1-800-736-0600 opt.4.

AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers

Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will for: " pCO2 give a result close to or just outside of the low end of the control range. (4.92 5.85 kPa or 36.9 46.9 mmHg) " pO2 give a considerable higher result than the expected assigned value of 13.9 -14.3 kPa (104-107 mmHg)

Radiometer sent a Safety Notice dated September 7, 2017, to all affected customers. The firm initiated their recall on 09/07/2017 by email. The letter requested the following: 1. Please check your inventory and analyzers for any boxes and ampoules of above mentioned QC. 2. Discard all Boxes and ampoules of this lot. 3. Complete the response form and return it to the number on the form. Please note: If you are not the end-user of the affected product, please ensure that this letter is distributed to the final end-user. Customers with questions were advised to contact their Radiometer representative.

TCM CombiM Modules 903-111

Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that can cause the alarm to sound higher than the pre-set maximum volume.

RadioMeter sent an Product Notification letter out on November 18, 2015, January 10, 2016 and March 29, 2016. The notification sent on November 18, 2015 and January 10, 2016, instructed customers a temporary solution of switching off the analyzer and then on again in order to re-establish the pre-set alarm volume. If alarm sound is higher than the pre-set volume customers are instructed to contact their local Radiometer service representative. If any questions contact Radiometer America Technical Support at 1-800-736--600 opt. 4. The notification sent on March 29, 2016, provided the same instructions and temporary solution. The notification also informed customers that the firm will be in contact with them to discuss the upgrade process.

ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.

Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.

Customer notification letters were sent 01/27/16. The letter provided the following instructions: The firm recommends that customers ensure that operators and clinicians using the "cord blood sample results from a HIS/LIS or a middleware system to determine treatment are made aware that arterial or venous is not transmitted. An upgraded version of the ABL90 and ABL800 series software will ensure that the full sample type cord blood arterial and cord blood venous will be transmitted to the HIS/LIS or middleware system. The new software version will be installed by local engineer when available. If not the end user customers are instruction to provide a copy of the recall notification letter to the end user. Any questions regarding this letter contact Radiometer America Technical Support at 1-800-736-0600 opt.1.

AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to track connected devices, monitor performance and availability, and to quickly resolve and document issues (including allowing the customer to track root cause and corrective action taken). Intended us

Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.

Radiomet4er sent a letter dated November 30, 2016, to all affected customers via email with a request for customers to complete a return form. Customers/Users were advised to not use the "more" button to expand patient results when viewing them in the AQURE patient view. Customers/Users Radiometer Representative will contact them to schedule a visit of a remote session. During the visit or remote session the representative will run a script on the AQURE system, which serve to remove the misalighnment possibility. It is noted in the letter to customers that expanding the results by using the More button will not affect the stored results. If customers are not the end-user of the affected product ensure that the notification letter is distributed to the final end-user. If any questions regarding the notification letter contact Radiometer America Technical Support at 1-800-736-0600 opt.1. For questions regarding this recall call 440-871-8900.

AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.

The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could lead to misinterpretation of results.

Customers were sent a notification letter on 12/29/15. The notification states that the AQURE System can be used, but to eliminate the potential confusion, blank fields for sample type are to be interpreted as not specified. Customers are told that a Radiometer representative will be in contact to schedule a visit or a remote session. During the visit or remote session the representative will run a database script on the AQURE system which will serve for two purposes: 1. Update existing patient results where the sample type field is blank to include Not specified. 2. Install a so-called database-trigger, which will include the text Not specified in a blank sample type field for future patient results. An upgraded version of the AQURE software will include modified device drivers to ensure that Not specified is inserted if the device transmits an empty field for sample type. The new software version will be installed by local engineer when available.

Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit N20 is used to apply tc Sensor 84 and tc Sensor 54 on the skin of a patient. TC sensor 84 and 54 are used with the TCM CombiM monitoring system and the Philips TcG10 module. The TCM CombiM monitoring system is intended for continuous transcutaneous monitoring of carbon dioxide (tcpCO2) and oxygen (tcpO2) partial pressures.

When the fixation ring is taken off the paper liner there is a potential for fractions of the paper liner's surface coating to stick to the surface of the ring.

Radiometer sent a Product Notification letter dated July 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. In the letter the firm requests that inventory be checked and removed for any the identified lot numbers for Fixation kit N20. The firm requests that the products be discarded. The letter states to complete p.2 and return it to their Radiometer representative. If you have any questions contact Radiometer America Technical Support at 1-800-736-0600 opt.4.

HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. Affected lots identified initially were 110705, 110706, 110715, 110716, 110717, 110718, 110719, and 110720. Subsequent investigation also identified as affected lots 1310227, 1310252

Batches of HemoCue Glucose 201 Microcuvettes show discoloration and provide results outside the specification at the end of their shelf life, approx. after 6 months. The HemoCue Glucose 201 Analyzer with plasma conversion multiplies the measured whole blood glucose value by a factor of 1.11 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are for In Vitro Diag

The consignees will be notified by a Field Safety Notice. Distributors will be instructed to forward the Field Safety Notice to their end customers and to secure that verification forms will be filled-out by end customers and returned to HemoCue.

ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.

The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can in some cases lead to a biased patient result.

Radiometer sent a Field Safety Notice dated December 17, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. What you should do short term: " Please ensure that the operator always closes the inlet when prompted by the analyzer, as per the labeling. " In case the inlet, by mistake, is not closed as per the labeling, please ensure that the following is carried out before measuring a patient sample: " Close the inlet and wait for the analyzer to go to READY (approximately five minutes) " Open the inlet and then close again (to initiate a Rinse) " Wait for the analyzer to go to READY (approximately 1 minutes) " Please return the confirmation fax form no. 1 to your RADIOMETER representative when the above actions have been implemented Final Solution provided by RADIOMETER: A mechanism will be provided in an upgraded version of the analyzer software to eliminate the possibility of this error. The new software version will be installed by your local engineer when available. Customers were instructed to ensure that this letter is distributed to the final end-user. Customers with questions were instructed to contact Radiometer America Technical Support at 1-800-736-0600, opt 4.

pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.

RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results.

On 7/18/2013, the firm sent Product Notification letters to their customers.

Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of samples of whole blood for the parameters pCO2, cK+,cNa+, cCa2+,cCl-,cGlu, cLac, cCrea, ctBil, and co-oximetry parameters,(ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF), in vitro testing of samples of expired air for the parameters pO2 and pCO2, in vitro testing of pleura samples for the pH parameter.

Negative drift on QC during in-use lifetime of CREA membranes can be observed.

Radiometer sent a Product Notification letter dated November 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to perform the following steps immediately: " Perform one quality control measurement using S7835 AutoCheck 6+, level 1 on already installed Crea membrane units to verify the Crea performance. If the QC result is out of range, new Crea A and Crea B membranes must be installed. Until further notice the following must be carried out every 24 hours: " Perform one quality control measurement using S7835 AutoCheck 6+, level 1 to verify the Crea performance. If the QC result is out of range, new Crea A and Crea B membranes must be installed. Please do not report Crea results unless the membrane unit has been verified as described above. If you already run S7835 AutoCheck 6+ level 1, every 24 hours, as part of your regular QC schedule, you do not need to do anything additional. Please review your QC results to ensure the results are within the QC range. Please complete and return the attached fax form, with your signature as soon as possible or within 7 days. Customers with questions were instructed to contact Radiometer America Technical Support at 1-800-736-0600, option 4. For questions regarding this recall call 440-871-8900, ext 209.

RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data.

Radiometer sent an Product Notification letter dated July 31, 2014 to affected customers via FedEx. The letter identified the affected product, problem and actions to be taken. The letter informed customers that local RADIOMETER IT specialist will contact customers in order to schedule the upgrade to v. 2.74 or 3.5.2. All RADIANCE versions below 2.7X will be upgraded to v. 2.74 or 3.5.2. For questions regarding this letter or the Recall, please contact Radiometer America Technical Support at 1-800-736-0600 opt.4.

ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21 Brnshj, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.

RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results.

Radiometer sent an Urgent Medical Device Recall letter dated November 5, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check all of their ABL90 FLEX analyzers and ensure that the analyzer is placed on a horizontal platform/table. If the analyzer is placed on a roll stand, please ensure that the support plate is aligned horizontally and locked in this position. Customers were asked to complete and fax the accompanying acknowledgment form in order to confirm their receipt of this field safety notice. Customers with questions were instructed to contact Radiometer America Technical Support at 1-800-736-0600, option 4. For questions regarding this recall call 440-871-8900.

pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen).

RADIOMETER became aware that the regarded lot pO2 units 942-042R0971 were produced with inner solution for pCO2 membrane units. This solution is a salt solution similar to the pO2 inner solution, but also contains glycerol which can be reduced at the cathode causing a suddenly rising zero current, causing the membrane unit to fail the following Cal2 calibration.

Radiometer sent a Product Notification letter dated June 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory and remove any affected product, discard all affected product in their possession, and complete page 2 of the letter and return to their Radiometer representative. Radiometer will replace any quantity of affected product they have at their location. Customers with questions were instructed to contact Radiometer America Technicial Support at 1-800-736-0600, opt 4. For questions regarding this recall call 440-871-8900, ext 209.

TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Brnshj, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.

RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.

On 11/30/2012 the firm sent an "Urgent Field Safety Notice" to their customers. The notification explained the issue and provided recommended actions. Customers may contact 1-800-736-0600 option 4 with questions.

S1827 Crea Calibration solution 1, 944-135, Lot DV-02 Radiometer Medical, Bronshoj Denmark Product Usage: The S1827 Crea Calibration Solution 1 (944-135) Lot DV-02 is a solution used by the ABL 8x7 series creatine analyzers to establish calibration points for measured parameters.

When the user activates the dosicap (containing the crea additive) and mounts it onto the bottle, the threads will not seal correctly causing approximately 10% of the solution to leak out when the bottle is placed horizontally for dissolving the additive. This will cause the concentration of creatinin and creatin in the calibration solution to be wrong, and results in a bias on the Crea results.

Radiometer sent a Medical Device Recall letter dated December 28, 2011 to their customers. The letter provided details on the affected devices, description of the problem and actions to be taken. The firm instructed their customers to immediately examine their stock and return any remaining product to Raiometer America Inc. for disposal. The letter states that Radiometer will replace all bottles of the affected lots, at no charge. Customers were asked to complete the attached Recall Response Fax Form and fax to 800-736-0601. For questions regarding the Recall contact Radiometer America Technical support at 1-800-736-0600 opt. 4.