FDAFDA · Food and drugs·Recall number Z-0022-2025
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Published October 16, 2024 · Recall initiated: August 26, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Qualigen Inc
- Distributor
- US: TX, MS, NY, OH, MT, WA, PA, MN, SC, GA, NC, NV, WY, AK, SD, KS, NE, VT, AL, MA, OK, UT, WI, IA, WV. OUS: Germany, Switzerland
- Lot
- UDI-DI: 00816467020099, Lot: 2405017-1, Expiration: 2025-05-15
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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