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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Beckman Coulter Access 2 Immunoassay Analyzers Recalled for Faulty Sample Motors

Agency Publication Date: March 17, 2025
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Summary

Beckman Coulter has recalled 873 units of the Access 2 Immunoassay Analyzer because an internal motor may have been manufactured with improper alignment. Due to a worn production tool used by a supplier, the sample motors can rub against internal components like the wheelbase plate and index sensor, potentially causing the machine to fail. This defect can lead to a significant delay in generating and reporting patient test results.

Risk

A faulty sample motor can cause the diagnostic analyzer to malfunction, which prevents laboratory staff from providing timely test results to doctors. While no injuries have been reported, delays in diagnostic information can negatively impact clinical decisions and patient care.

What You Should Do

  1. This recall involves the Access 2 Immunoassay Analyzer (Catalog Number 81600N) with Unique Device Identifier (UDI) 15099590265380.
  2. Identify if your device is part of this recall by checking the serial number printed on the device label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact Beckman Coulter or your authorized distributor to arrange for a technician to inspect the analyzer and perform any necessary repairs or corrections.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Access 2 Immunoassay Analyzer
Model / REF:
81600N
Serial Numbers (872):
574626
574627
574839
574840
574841
574842
574852
574853
574854
574378
573724
574432
574538
574907
574497
574303
574184
574218
574219
574305
574332
574333
574345
574346
574414
574451
574581
574582
574583
574584
574726
574727
574728
574729
574730
574731
574732
574733
574920
574922
574923
574955
574957
574958
574959
574984
574985
574986
574987
574811
UDI:
15099590265380

Catalog Number: 81600N

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96248
Status: Active
Manufacturer: Beckman Coulter, Inc.
Sold By: Beckman Coulter; authorized distributors
Manufactured In: United States
Units Affected: 873 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.