Radiometer Medical ApS recalls The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is…
In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing FHbF and ctBil, 2)…
Read the official notice →- Date
- 2026-10-21
- Country
- United States
- Brand
- Radiometer Medical ApS
- Product
- The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is…
- Classification
- Class II
- Units
- US Nationwide distribution including in the states of CA, OH, LA, MA, FL, NY,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
Radiometer 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
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
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
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
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 →
USOther drugs & medical recalls in the United States
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Viatris, Inc. recalls Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown,…
Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications
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Out of specification due to dissolution.
- 2026-10-21
Medline Industries, LP recalls Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A
Discrepancy in the shelf-life of a component
Healthmark Industries Co., Inc. recalls Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED…
Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.
FDA · DeviceHealthmark Industries Co., Inc.Worldwide distribution - US Nationwide and the countries of JAPAN, AUSTRALIA,…Official notice →Merit Medical Systems, Inc. recalls Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical…
The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.