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
Read the official notice →- Date
- 2024-07-31
- Country
- United States
- Brand
- Beckman Coulter
- Product
- Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Beckman Coulter recalls
- 2024-09-04
USBeckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the states of CA, FL, GA, IN, KS,…Official notice →- 2024-08-21
- US
Beckman Coulter, Inc. recalls Discrete photometric chemistry analyzer for clinical use.
Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoassay System Analyzers that appear to be caused by misaligned index wheels housed within the reagent carousel module.…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the states of NE, MT, LA, TX, NY,…Official notice → - US
Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below;…
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide distribution in the states of CA, FL,…Official notice → - 2024-07-31
- US
Beckman Coulter, Inc. recalls Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the states of FL, IN, KS, NH, PA,…Official notice → - 2024-07-10
- US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found…
- US
Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro…
The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex cable assembly fittings during normal operation. The DxI 9000…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the state of Indiana and the…Official notice →
Other drugs & medical recalls in the United States
- 2024-07-31
- US
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Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with…
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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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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…
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