Bio-Rad Laboratories: QXDx BCR-ABL %IS Kit Recalled for Potential Incorrect Results

Agency Publication Date: March 22, 2024

Summary

Bio-Rad Laboratories is recalling 33 units of the QXDx BCR-ABL %IS Kit due to an issue with calibrations and controls. This defect can cause the kit to report incorrectly low molecular response values, which could lead to inaccurate medical assessments. These diagnostic kits were distributed to laboratory facilities in Florida, Minnesota, Pennsylvania, South Dakota, and Texas. Because this is a specialized medical diagnostic tool, consumers should contact their healthcare provider or Bio-Rad Laboratories for further instructions regarding test results performed with these specific lots.

Risk

Incorrect calibrations within the test kit may lead to the reporting of false-low percentages and molecular response values. This poses a risk of misinterpreting a patient's clinical status or the effectiveness of their treatment.

What You Should Do

Identify if your facility has the Bio-Rad QXDx BCR-ABL %IS Kit (REF: 12005660) by checking the packaging for Lot numbers 64562656 or 64571846.
Verify the Universal Device Identifier (UDI) number 03610521162834 printed on the product label to confirm it matches the recalled units.
Immediately stop using any kits from the affected lots and secure them to prevent further diagnostic testing.
Contact Bio-Rad Laboratories at their Pleasanton, California headquarters or your local representative to arrange for a remedy and to discuss the impact on previously reported test results.
If you are a patient who has recently undergone testing with this kit, contact your healthcare provider to determine if re-testing is necessary.
For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer and healthcare coordination

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

Affected Products

Product: Bio-Rad QXDx BCR-ABL %IS Kit

Model / REF:

REF: 12005660

UPC Codes:

03610521162834

Lot Numbers:

64562656

64571846

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94020

Status: Active

Manufacturer: Bio-Rad Laboratories

Sold By: Laboratory distributors

Manufactured In: United States

Units Affected: 33 units

Distributed To: Pennsylvania, South Dakota, Texas, Florida, Minnesota

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 if your facility has the Bio-Rad QXDx BCR-ABL %IS Kit (REF: 12005660) by checking the packaging for Lot numbers 64562656 or 64571846.

Verify the Universal Device Identifier (UDI) number 03610521162834 printed on the product label to confirm it matches the recalled units.

Immediately stop using any kits from the affected lots and secure them to prevent further diagnostic testing.

Contact Bio-Rad Laboratories at their Pleasanton, California headquarters or your local representative to arrange for a remedy and to discuss the impact on previously reported test results.

If you are a patient who has recently undergone testing with this kit, contact your healthcare provider to determine if re-testing is necessary.

For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.