Reported Oct 16, 2024 · Ongoing
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP…
Qualigen Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Qualigen Inc · 2042 Corte Del Nogal · Carlsbad, CA · 92011-1438
Is this the product you have?
- FastPack TSH Calibrator Kit
- REF25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
- Lot codes and dates
- UDI-DI00816467020099
- Lot2405017-1
- Expiration2025-05-15
- Amount recalled
- 60
Where it was sold
Why it was recalled
Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtained could be higher than expected.
This product could cause temporary or reversible health problems — stop using it.
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