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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

Access 2 Reaction Vessels Recalled for Manufacturing Deformities

Agency Publication Date: December 9, 2025
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Summary

Beckman Coulter, Inc. is recalling 38,225 units of Access 2 Reaction Vessels (Catalog Number 81901), which are disposable plastic tubes used to process patient samples on laboratory testing systems. The vessels may have small manufacturing deformities, such as hair-like protrusions on the bottom, that can cause laboratory instruments to error during testing. These errors can stop the testing process and lead to significant delays in providing results to patients.

Risk

The deformed vessels can interfere with the internal moving parts of the laboratory instrument, causing malfunctions that stop the analysis. This can result in laboratory delays and potentially affect the timing of medical diagnoses and patient care.

What You Should Do

  1. The recalled products are Access 2 Reaction Vessels (Catalog Number 81901) with UDI-DI 15099590180249, which are individual plastic tubes used on the Access 2 Immunoassay system.
  2. Check the lot number and UDI-DI printed on the product packaging to determine if your supplies are affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product immediately. Contact Beckman Coulter, Inc. or your distributor to arrange for a return, replacement, or correction of the vessels.
  4. Call the FDA at 1-888-463-6332 for additional questions regarding this recall.

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 Reaction Vessels
Variants: Individual, disposable, plastic tubes
Model / REF:
81901
Lot Numbers:
P243943
P243971
P244202
P244344
P244345
P250001
P250002
P250003
P250004
P250005
UDI:
15099590180249

Used to process patient, quality control and calibration samples on the Access 2 Immunoassay system.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97932
Status: Active
Manufacturer: Beckman Coulter, Inc.
Sold By: Beckman Coulter, Inc.; Authorized distributors
Manufactured In: United States
Units Affected: 38,225 untis
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.