Drugs & medicalClass II

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…

Read the official notice →
Date
2025-04-30
Country
United States
Brand
Radiometer Medical ApS
Product
Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number…
Classification
Class II
Units
U.S.: AL, AR, AZ, BM CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

  1. 2024-07-31
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    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 →
  3. 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 →
  5. 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 →
  7. 2022-05-25
  8. US
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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 →
All 5 Radiometer Medical ApS recalls →

Other drugs & medical recalls in the United States

  1. 2025-04-30
  2. US
    Drugs & medicalClass II

    Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer

    When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose…

    FDA · DeviceBeckman Coulter, Inc.Worldwide distribution.Official notice →
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    IHB OPERATIONS B.V. recalls Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

    The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engagement to support the weight of the frame and monitor. This could lead to a failure of the mounting hardware…

    FDA · DeviceIHB OPERATIONS B.V.US Nationwide distribution including in the states of AL, AZ, CA, FL, IA, ID,…Official notice →
  4. US
    Drugs & medicalClass II

    Philips North America Llc recalls Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

    Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.

    FDA · DevicePhilips North America LlcWorldwide distribution: US (Nationwide); and OUS (Foreign) to countries of:…Official notice →
  5. US
    Drugs & medicalClass II

    Edge Biologicals Inc recalls Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of…

    Due to product outer packaging incorrectly labeled.

    FDA · DeviceEdge Biologicals IncU.S. Nationwide distribution in the state of PA.Official notice →
  6. US
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    Globus Medical, Inc. recalls MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;

    Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.

    FDA · DeviceGlobus Medical, Inc.US Nationwide distribution in the state of AR.Official notice →
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    Abbott Laboratories recalls Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product…

    When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is…

    FDA · DeviceAbbott LaboratoriesWorldwide distribution: US (nationwide) to the following states: AR, AZ, CA,…Official notice →
See all drugs & medical recalls →