Radiometer Medical ApS Akandevej 21 Bronshoj Denmark Recalls
Showing 1-14 of 14 recalls
ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted through the sample. This will lead to a perturbed and non-linear absorbance spectrum which results in measurement errors.
Two Urgent Medical Device Recall Letters were sent to customers at the user level via email followed by a hard copy letter sent FedEx 2nd day with tracking and proof of delivery. The first letter, dated 11-21-2019, was intended for customers not utilizing the analyzer for measuring blood samples from newborn babies of up to four weeks of age. The letter informed customers of biased results for tbil, that the bias increases with tHb concentration, and that the increase is not linear. Customers were informed of the potential risks to patients, and were requested to complete the Recall Response Form with hospital name, serial numbers of affected devices, and to indicate whether or not the device(s) is/are used for measuring blood samples from newborn babies of up to four weeks of age and tBil is actually reported, or if the device(s) is/are no longer in use. Response forms were requested to be sent by fax or email to their Radiometer Representative (Fax No.: 714 582 0806; Email: RECALL@RADIOMETERAMERICA.COM). Customers were informed that their local Radiometer representative would, in conjunction with a future planned visit, check if the customers' analyzer includes an affected hemolyzer unit, and if so, exchange the hemolyzer unit. Customers who are not end users of the device were requested to ensure that this letter was distributed to the final end-user. Customers with questions were instructed to contact their Radiometer representative. The second letter, also dated 11-21-2019, was intended for customers using the analyzer for measuring blood samples from newborn babies of up to four weeks of age, where total Bilirubin (tBi)l is actually reported. This letter also informed customers of the bias increases with tHb concentration, and that the increase is not linear. Risks for newborn babies up to four weeks were described. Customers were requested to take one of two actions until Radiometer had developed a solution for this issue. Choice of interim actions incl
PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler product line for collection of arterial samples for pH, blood gas, oximetry, electrolyte and metabolite analysis. Model Number/Product Description: 956-518 PICO70 w/o needle; 956-519 PICO70 w/o needle; 956-522 PICO70 22G x 25 mm; 956-525 PICO70 22G x 32 mm; 956-529 PICO70 23G x 16 mm; 956-533 PICO70 23G x 25 mm; 956-534 PICO70 23G x 32 mm; 956-547 PICO70 25G x 16 mm;
Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. The issue relates to the sterile barrier system for the product. During internal stress testing on PICO70 Arterial Blood Samplers a breach in the sterile barrier system was observed in one sample. Risk for the patient: The described error is considered to have a remote possibility of resulting in bacterial bloodstream infection. The bloodstream infection may be asymptomatic but may also progress to sepsis or life-threatening septic shock. Immunosuppressed patients are at particular risk. Due to issues (breaches) with the sterile barrier system for the Arterial Blood Sampler.
On 03/26/2021, the firm initially sent an "Urgent: Medical Device Recall" Notification Letter via email and followed up with a hardcopy via FedEx. The Notification Letter informed customers that the Recalling Firm had become aware of an issue related to the sterile barrier system for its arterial blood sampler product. The potential risks associated with the affected products could potentially be bacterial bloodstream infection with immunosuppressed patients being at particular risk. Customers are instructed to: 1) Check their inventory of the affected Arterial Blood Samplers 2) Check for the affected Arterial Blood Samplers that were distributed within their institution. 3) Collect any of the affected Arterial Blood Samplers 4) Complete the Recall Response Form (last page of this letter) and return to the fax number listed on the form. 5) For U.S. Customer return affected Arterial Blood Samplers to: Radiometer America 810 Sharon Drive Westlake, OH, 44145 Attn: RGA (ID) Any questions, contact 1-800-736-0600 option 1, Monday - Friday 9am to 7pm (EST).
ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using a check digit for patient ID or accession number. Misinterpretation of a barcode, including e.g. patient ID or accession number, may result in patient mix up and/or delayed medical treatment.
The firm will send consignees Urgent Medical Device Recall Letter dated 5/11/2020 via email and FedEx 2nd day delivery with proof of delivery on 5/11/2020 informing them that Radiometer has become aware that the internal barcode reader, included in every ABL80 FLEX Series analyzers, may potentially misinterpret the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. The issue identified only relates to barcode types not using a check digit. A check digit enables the barcode reader to validate the data read, and hence, to capture if the barcode has been misinterpreted and consequently to reject such data. For barcodes without a check digit, the following factors may add to the risk of misinterpretation: " Poor paper quality " Poor printer quality " Improper handling of the barcode (e.g. the barcode is folded or exposed to liquid) Radiometer uses only barcode types with a check digit when producing barcode labels used for e.g. sampler identification. They request customers to take the following actions: Check if their institution is using barcode types without a check digit, including e.g. patient ID or accession number, to be read on the ABL80. 1. If you use barcode types without a check digit, Radiometer recommends to either: o Enable the check digit on the barcode type currently used, or o Change the type of barcode to one that includes a check digit, as this enables the barcode reader to validate the data read, and hence, to recognize if the barcode has been misinterpreted and consequently to reject such data.2. If you use barcode types with a check digit, the barcode reader already validates the data read and is able to identify if the barcode has been misinterpreted and consequently rejects such data. Hence, no short-term action is required. 3. If you do not use locally generated barcodes to be read by the ABL80, no short-term action is required.
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and ABL800Basic. The FlexQ module is optional and can be added to all models and configurations.
Potential risk of patient mix-up on analyzers due to software issues.
On 05/26/2020, the firm sent an Urgent: Medical Device Recall letter via email to all consignees; additionally the firm will send a hard copy letter FedEx 2nd day with tracking and proof of delivery.
ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, 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.0693938004 and 393-801/05700693938011 - Product Usage:
Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ID or accession number. The issue is related to barcode types not using a check digit. This could result in patient mixup or loss of sample resulting in delayed medical treatment
On 3/10/2020, a "Urgent: medical Device Recall" letter was sent via email and FedEx to affected consignees. In addition to informing the consignee about the recall issue, the recall notification asked customers to take the following action: Check if your institution is using barcode types without a check digit, including e.g. patient ID or accession number, to be read on the ABL800. 1. If you use barcode types without a check digit, Radiometer recommends to either: - Enable the check digit on the barcode type currently used, or - Change type of barcode to one that includes a check digit, as this enables the barcode reader to validate the data read, and hence, to capture if the barcode has been misinterpreted and consequently to reject such data. 2. If you use barcode types with a check digit the barcode reader already validates the data read, and hence, captures if the barcode has been misinterpreted and consequently rejects such data. Hence, no action required. 3. If you do not use barcodes to be read by the ABL800, no action required. 4. Complete the Recall Response Form (last page of this letter) and submit to your Radiometer distributor. 5. If you have any questions, please contact us at 1-800-736-0600 option 1, Monday Friday 9am EST to 7pm EST. Solution provided by Radiometer Radiometer has released software version V6.19, which we will install on your analyzer, disregarding which barcode type is used, or no barcodes are used at all. The new software version scans the barcode three times (as opposed to once in previous versions). For barcode types without a check digit, this change may potentially reduce the risk of misinterpretation, if caused by the factors, which may add to the risk of misinterpretation, mentioned above.
ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. This could result is patient mixup and/or lost of sample, resulting in delayed medical treatment.
On 2/3/2020, the firm provided affected consignees with a "Urgent: Medical Device Recall" letter via Email, and hard copy letter via FedEx 2nd day. In addition to providing the recall notification, consignees were asked to take the following actions: Check if your institution is using barcode types without a check digit, including e.g. patient ID or accession number, to be read on the ABL90. 1. If you use barcode types without a check digit, Radiometer recommends to either: - Enable the check digit on the barcode type currently used, or - Change type of barcode to one that includes a check digit, as this enables the barcode reader to validate the data read, and hence, to capture if the barcode has been misinterpreted and consequently to reject such data. 2. If you use barcode types with a check digit the barcode reader already validates the data read, and hence, captures if the barcode has been misinterpreted and consequently rejects such data. Hence, no action required. 3. If you do not use barcodes to be read by the ABL90, no action required. 4.Complete the Recall Response Form (last page of this letter) and submit to your Radiometer distributor. Solution provided by Radiometer Radiometer has released software version V3.4 MR2, which we will install on your analyzer, disregarding which barcode type is used, or no barcodes are used at all. The new software version scans the barcode three times (as opposed to once in previous versions). For barcode types without a check digit, this change may potentially reduce the risk of misinterpretation, if caused by the factors, which may add to the risk of misinterpretation, mentioned above.
safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1
The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.
The method of notification of the recall was a customer letter sent to all consignees via email and a hard copy sent via FedEx 2nd day with tracking and proof of delivery; date of issue was 3/17/20. Customers were instructed to do the following with the recalled product: -Cease using the Blood Samplers from the affected lots. -Check inventory of Blood Samplers from the affected lots. -Check for Blood Samplers from the affected lots distributed in the institution. -Collect any Blood Samplers from the affected lots. -Complete the Recall Response Form (last page of the customer advisory letter) and return it to the representative. -Discard the collected Blood Samplers of the affected lots. For any questions contact at 1-800-736-0600 option 1, Monday-Friday, 9am EST to 7pm EST.
ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.
On May 20, 2022, Radiometer issued a "Urgent: Medical Device Recall" notification to affected consignees via: Email and FedEx 2nd day Mail. Radiometer ask consignees to take the following actions: 1. For the affected micro measuring modes Radiometer kindly requests you to not use results for cNa+. The most efficient way to ensure this is to remove the parameter from the affected modes as per the procedures included within the letter. 2. Please complete the Recall Response Form and return to your Radiometer representative (recall@radiometeramerica.com).
TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) - Product Usage: It is indicated for use on pediatrics and adults.
Reports have been received about the transcutaneous monitoring system display flickering or monitor becoming non responsive and beeping. This may result in delayed patient monitoring as well as potentially compromise the product performance.
On February 20, 2020, a "Urgent: Medical device Recall" letter was sent to affected consignees via E-Mail and FedEx 2nd day delivery. In addition to informing consignees about the recall, the customer notification asked customers to take the following actions: 1. Cease using the affected TCM4 Base unit and put it on quarantine. 2. Complete the Recall Response Form (last page of this letter) and submit to your Radiometer representative. 3. Your Radiometer representative will exchange the computer hardware of your TCM4 Base unit as soon as possible when we receive replacement components. 4. If you are not the end-user of the affected product, please ensure that this letter is distributed to the final end-users. 5. If you have any questions, please contact us at 1-800-736-0600 option 1, Monday Friday 9am EST to 7pm EST
AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles.
The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some third-party devices. The error may lead to serious adverse health consequences for the patient caused by patient data mix-up.
On 07/15/2019, the firm, Radiometer America, Inc., sent an "Urgent: Medical Device Correction" to customers via FedEx with tracking and email to inform them that the firm has become aware that there is a potential problem related to its system that may result in patient mix-up when connected to some third-party devices. This recall affects all system below version 2.3.5. On September 24th, the firm sent a updated letter via email which updated that only 7 third party devices could be potentially affected (Originally 10 third party devices). The firm is instructing customers to: If the customer's affected system is connected to a third-party device, the Recalling Firm is requesting the customer to inform operators to cease performing queries as described in the scenario above until the affected system has been corrected by the Recalling Firm's representative. Additionally, the firm is asking that the customer please complete the Recall Response Form (last page) and return it to the fax number (714-582-0806) or email address provided (RECALL@READIOMETERAMERICA.COM). For any additional questions, customers are instructed to contact their Recalling Firms representative; or 440-925-34875 or email: jgibbons@radioamerica.com.
Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE
Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.
On April 26, 2022 Radiometer issued a "Urgent Medical Device Recall" notification via Email. The firm ask consignees to take the following actions: Radiometer kindly request you to stop using the affected product with immediate effect. To ensure patient safety in your facility, kindly follow the steps below: " Check your inventory of the above PICO50 Arterial Blood Samplers " Check for the above PICO50 Arterial Blood Samplers distributed in your institution. " Collect any of the above PICO50 Arterial Blood Samplers and put on quarantine " Complete the Recall Response Form (last page of this letter) and return to your Radiometer representative together with the quarantined PICO50 Arterial Blood Samplers. To ensure you receive credit for the PICO50 Arterial Blood Samplers, please contact Customer Service @ CSRsupport@radiometeramerica.com to receive a Return Goods Authorization
Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
On 04/14/2021, the firm initially sent an "Urgent: Medical Device Recall" Letter via email with a follow-up hardcopy via FedEx 2nd Day to customers inform them the Recalling Firm has become aware of a potential for the analyzers internal clocks may become incorrect. For analyzers which do not have an internal battery installed the incorrect time may be triggered in case power is abruptly removed from the analyzer, by e.g. toggling the power switch on the analyzer itself or at the wall outlet, or a power failure occurs on the mains supply. When the analyzer is switched on again, the analyzers internal clock may behave as in the example below: -The clock starts at 08:00 -The clock runs normally until it reaches 08:59:59 -The clock resets to 08:00 Once the issue has been triggered the clock will continue to run in an infinite loop between 08:00 and 08:59 and the date will remain the same. This means that all patient samples run after the issue has been triggered will have a time stamp suggesting they have been run between 08:00 and 08:59 on the same day. This situation has the following additional consequences: -Scheduled Quality Controls (QC) are not run -Scheduled Calibrations are not run -No notification of scheduled replacements & maintenance activities -No notification of expiration of Sensor Cassette (SC) and Solution Pack (SP) -Analyzer can accept expired consumables -Expired Sample age not error marked -Reference ranges and critical limits flagging based on wrong patient age -Incorrect time stamp on results and messages send to external systems such as AQURE and HIS/LIS. Risks for the Patients-The described error is considered to have a possibility of resulting in immediate as well as long range serious or life-threatening adverse health consequences to the patient. The described error may lead to the analyzers reporting negative as well as positive biases for all parameters outside the analyzer specifications, as Calibrations are not perfor
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.
On 3/5/2020 a "Urgent: Medical device Recall" letter was hand delivered to effective consignees. In addition to providing information on the recall products, the customer notification as consignees to take the following actions: Solution provided by Radiometer: 1. Your Radiometer representative will exchange the power supply of your ABL800 analyzer at the earliest convenience. Your Actions: 1. Cease using the affected ABL800 analyzer and put it on quarantine. 2. Shut down the affected ABL800 analyzer and disconnect the power cord. 3. Complete the Recall Response Form (last page of this letter) and submit to your Radiometer representative 4. If you have any questions, please contact us at 1-800-736-0600 option 1, Monday Friday 9am EST to 7pm EST.
AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets the user send commands to selected devices. The system uses data related to the performance of devices, to tell users
There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may result in patient mix-up.
Radiometer Medical sent a Notification letter dated February 27, 2018 to customers. The letter identified the affected product, problem and actions to be taken For questions contact your Radiometer representative.