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Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Radiometer Medical ApS Akandevej 21 Bronshoj Denmark Recalls

All product recalls associated with Radiometer Medical ApS Akandevej 21 Bronshoj Denmark.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Mar 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 21 recalls

ABL90 Series (Radiometer) – analyzer freeze risk (2025)

ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (watchdog) that detects a freeze and automatically restarts the software to continue operating the analyzer. However, even if a restart occurs, any sample being processed at that time will be lost, potential to lead to delay in test results.

FDAMar 21, 2025AL, AZ, AR +46 more• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

ABL800 FLEX Analyzer (Radiometer) – Calibration Solution Issue (2024)

Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples.

FDAMay 31, 2024Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Radiometer Medical ApS Akandevej 21 Bronshoj Denmark: AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2....

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Due to potential software issue that may result in patient mix-up information.

FDAMar 8, 2023Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Radiometer Medical ApS Akandevej 21 Bronshoj Denmark: 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+.

FDAMay 18, 2022Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Radiometer Medical ApS Akandevej 21 Bronshoj Denmark: Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1...

Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.

FDAApr 8, 2022Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Radiometer Medical ApS Akandevej 21 Bronshoj Denmark: Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. ...

Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

FDAApr 14, 2021Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Radiometer Medical ApS Akandevej 21 Bronshoj Denmark: Radiometer ABL90 FLEX Analyzer with E3800 PC units. The ...

Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

FDAApr 14, 2021Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Radiometer Medical ApS Akandevej 21 Bronshoj Denmark: E3800 PC Units (spare parts)

Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

FDAApr 14, 2021Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Radiometer Medical ApS Akandevej 21 Bronshoj Denmark: PIC070 Arterial Blood Sampler PICO70 - Product Usage: Pre...

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.

FDAMar 26, 2021Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Radiometer Medical ApS Akandevej 21 Bronshoj Denmark: Blood gases (PCO2, PO2) and blood pH test system; ABL800 ...

Potential risk of patient mix-up on analyzers due to software issues.

FDAMay 26, 2020AL, AZ, AR +43 more• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Radiometer Medical ApS Akandevej 21 Bronshoj Denmark: ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: ...

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.

FDAMay 11, 2020Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Radiometer Medical ApS Akandevej 21 Bronshoj Denmark: ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE,...

FDAMay 11, 2020Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Radiometer Medical ApS Akandevej 21 Bronshoj Denmark: safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1

The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.

FDAMar 17, 2020AL, AK, AR +35 more• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Radiometer Medical ApS Akandevej 21 Bronshoj Denmark: ABL800 FLEX, model number/UDI 393-800/0570 In Vitro test...

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

FDAMar 10, 2020Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Radiometer Medical ApS Akandevej 21 Bronshoj Denmark: ABL800 FLEX model number 393-800 and 393-801, UDI:(01)057...

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.

FDAMar 6, 2020CA, IN• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Radiometer Medical ApS Akandevej 21 Bronshoj Denmark: TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used...

Laceration Risk

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.

FDAFeb 20, 2020Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Radiometer Medical ApS Akandevej 21 Bronshoj Denmark: ABL90 FLEX Analyzer, Model Numbers 393-090, with software...

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.

FDAFeb 3, 2020Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Radiometer Medical ApS Akandevej 21 Bronshoj Denmark: ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product ...

FDAFeb 3, 2020Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Radiometer Medical ApS Akandevej 21 Bronshoj Denmark: ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyz...

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.

FDANov 21, 2019Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Radiometer Medical ApS Akandevej 21 Bronshoj Denmark: ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer U...

FDANov 21, 2019Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark