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…
Read the official notice →- Date
- 2024-07-31
- Country
- United States
- Brand
- Radiometer Medical ApS
- Product
- 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…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution including in the states of AL, AR,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Radiometer Medical ApS recalls
- 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 →- 2023-04-26
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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
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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
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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 →
Other drugs & medical recalls in the United States
- 2024-07-31
- US
Abbott Medical recalls Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
FDA · DeviceAbbott MedicalWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - US
Beckman Coulter Inc. recalls Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal
FDA · DeviceBeckman Coulter Inc.Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - US
Medtronic Neuromodulation recalls A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605,…
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Randox Laboratories Ltd. recalls RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers.…
Cystatin C Reagent marketed without a 510 (k)
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of AL, CA, GA, NY.Official notice → - US
Embecta Corp. recalls BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number:…
BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February 29, 2024. Using a device past its expiry sterility and integrity of the device cannot be guaranteed.
- US
Medtronic Perfusion Systems recalls TourniKwik Tourniquet Set (CFN 79012)
Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
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