Radiometer Medical ApS recalls
5 official recalls and safety alerts involving Radiometer Medical ApS since 2022-05, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Radiometer Medical ApS or the relevant agency.
- 2025-04-30
USRadiometer Medical ApS recalls Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number…
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…
FDA · DeviceRadiometer Medical ApSU.S.: AL, AR, AZ, BM CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…Official notice →- 2024-07-31
- US
Radiometer Medical ApS recalls ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for…
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…
FDA · DeviceRadiometer Medical ApSWorldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice → - 2023-04-26
- US
Radiometer Medical ApS recalls AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and…
Due to potential software issue that may result in patient mix-up information.
FDA · DeviceRadiometer Medical ApSWorldwide - U.S. Nationwide including in the states of AL, AR, AZ, CA, CO, CT,…Official notice → - 2022-07-13
- US
Radiometer Medical ApS recalls 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+.
FDA · DeviceRadiometer Medical ApSWorldwide distribution - US Nationwide distribution in the states of AR, AZ,…Official notice → - 2022-05-25
- US
Radiometer Medical ApS recalls Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only,…
Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.
FDA · DeviceRadiometer Medical ApSWorldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice →