Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FastPack TSH Calibrator Kit Recalled by Qualigen Inc Due to Thyroid Stimulating Hormone (TSH) calibrator card has an...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Qualigen Inc directly.
Affected Products
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Quantity: 60
Why Was This 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.
Where Was This Sold?
This product was distributed to 25 states: AL, AK, GA, IA, KS, MA, MN, MS, MT, NE, NV, NY, NC, OH, OK, PA, SC, SD, TX, UT, VT, WA, WV, WI, WY
About Qualigen Inc
Qualigen Inc has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report