Beckman Coulter, Inc.: Access Thyroglobulin Calibrators Recalled for Understating Patient Results

Agency Publication Date: October 11, 2023

Summary

Beckman Coulter, Inc. is recalling approximately 5,980 units of Access Thyroglobulin Calibrators used with Thyg reagent packs. An internal investigation revealed that certain calibrator cards distributed in April 2023 cause patient test results to be approximately 11% lower than they actually are. This defect could lead to the misinterpretation of clinical data by healthcare providers.

Risk

The incorrect calibration causes a systematic decrease in measured thyroglobulin levels, which may result in healthcare providers underestimating a patient's thyroid markers, potentially affecting treatment decisions or monitoring of thyroid conditions.

What You Should Do

Identify your product by checking for 'Access Thyroglobulin Calibrators' with UDI/DI 15099590227166.
Check the packaging or documentation for the following affected Lot Numbers: 233806, 234171, 234355, 234443, 234444, 234617, or 337940.
Contact your healthcare provider or the manufacturer, Beckman Coulter, Inc., immediately to determine if your previous test results were affected and to obtain further instructions.
Laboratories and clinics should discontinue use of the affected calibrator cards from these specific lots immediately.
For additional information or questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

Other Action

Manufacturer and Healthcare consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Access Thyroglobulin Calibrators

Model / REF:

UDI/DI 15099590227166

Lot Numbers:

233806

234171

234355

234443

234444

234617

337940

Date Ranges: Distributed April 2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92670

Status: Active

Manufacturer: Beckman Coulter, Inc.

Sold By: Diagnostic laboratories; Healthcare facilities

Manufactured In: United States

Units Affected: 5980 units

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 · 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.

Summary

What You Should Do

Identify your product by checking for 'Access Thyroglobulin Calibrators' with UDI/DI 15099590227166.

Check the packaging or documentation for the following affected Lot Numbers: 233806, 234171, 234355, 234443, 234444, 234617, or 337940.

Contact your healthcare provider or the manufacturer, Beckman Coulter, Inc., immediately to determine if your previous test results were affected and to obtain further instructions.

Laboratories and clinics should discontinue use of the affected calibrator cards from these specific lots immediately.

For additional information or questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).