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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 Thyroglobulin Assay Recalled for Erroneously High Results

Agency Publication Date: August 13, 2025
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Summary

Beckman Coulter, Inc. is recalling 453 units of the Access Thyroglobulin assay (Catalog Number 33860) from lot 439163. This laboratory test, used to monitor patients for recurrent thyroid cancer, may generate incorrectly high results. Laboratory supervisors and healthcare providers should stop using the affected lot immediately and contact the manufacturer for a replacement.

Risk

Falsely increased test results may lead physicians to perform unnecessary diagnostic imaging studies or make inappropriate therapy adjustments in patients being monitored for residual or recurrent thyroid cancer.

What You Should Do

  1. This recall involves the Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, sold under Catalog Number 33860 and identified by lot number 439163 (UDI-DI 15099590227173).
  2. Stop using the recalled product immediately.
  3. Contact Beckman Coulter, Inc. or your distributor to arrange for a return, replacement, or correction of the affected reagent units.
  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 Thyroglobulin assay
Model / REF:
33860
Lot Numbers:
439163
UDI:
15099590227173

Simultaneous one-step immunoenzymatic assay.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97255
Status: Active
Manufacturer: Beckman Coulter, Inc.
Sold By: Beckman Coulter authorized distributors; Direct laboratory sales
Manufactured In: United States
Units Affected: 453 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.