Qualigen Inc: FastPack TSH Calibrator Kit Recalled Due to Potential for Incorrect Results

Agency Publication Date: October 8, 2024

Summary

Qualigen Inc. is recalling 60 units of the FastPack TSH Calibrator Kit because a barcode error on the calibrator card is linked to incorrect information. While the system may appear to calibrate successfully, this defect can cause thyroid-stimulating hormone (TSH) test results for patients to appear higher than they actually are. This kit is used in clinical settings with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer to help diagnose thyroid conditions. Consumers should contact their healthcare provider or the manufacturer regarding the 60 affected units distributed in late 2024.

Risk

The incorrect barcode allows the system to run with the wrong calibration data, which may lead to falsely elevated TSH results. This could potentially result in a patient receiving an incorrect diagnosis or inappropriate medical treatment for a thyroid condition.

What You Should Do

Immediately identify if you have the FastPack TSH Calibrator Kit (REF: 25000024) by checking the packaging for UDI-DI 00816467020099 and Lot number 2405017-1.
Verify the expiration date on the kit is 2025-05-15 to confirm it is part of the affected recall.
Stop using the affected calibrator kits immediately to prevent inaccurate diagnostic results.
Contact your healthcare provider or Qualigen Inc. directly at their Carlsbad, California office to receive further instructions on how to handle the defective kits and to discuss potential refunds or replacements.
Healthcare providers who used this specific lot should evaluate whether previously reported TSH results for patients need to be reviewed or if patients need to be retested.
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 Notification and Guidance

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

Affected Products

Product: FastPack TSH Calibrator Kit

Model / REF:

REF: 25000024

UPC Codes:

00816467020099

Lot Numbers:

2405017-1

Date Ranges: Expiration: 2025-05-15

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95326

Status: Active

Manufacturer: Qualigen Inc

Sold By: Clinical laboratories; Healthcare facilities

Manufactured In: United States

Units Affected: 60

Distributed To: Texas, Mississippi, New York, Ohio, Montana, Washington, Pennsylvania, Minnesota, South Carolina, Georgia, North Carolina, Nevada, Wyoming, Alaska, South Dakota, Kansas, Nebraska, Vermont, Alabama, Massachusetts, Oklahoma, Utah, Wisconsin, Iowa, West Virginia

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

Immediately identify if you have the FastPack TSH Calibrator Kit (REF: 25000024) by checking the packaging for UDI-DI 00816467020099 and Lot number 2405017-1.

Verify the expiration date on the kit is 2025-05-15 to confirm it is part of the affected recall.

Stop using the affected calibrator kits immediately to prevent inaccurate diagnostic results.

Contact your healthcare provider or Qualigen Inc. directly at their Carlsbad, California office to receive further instructions on how to handle the defective kits and to discuss potential refunds or replacements.

Healthcare providers who used this specific lot should evaluate whether previously reported TSH results for patients need to be reviewed or if patients need to be retested.

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.