Device product
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Z-0022-2025
Product summary
- Firm
- Qualigen Inc
- Event
- Event 95326
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 60
- Official record key
device-enforcement:Z-0022-2025
Official wording
Reason: 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.
Code information: UDI-DI: 00816467020099, Lot: 2405017-1, Expiration: 2025-05-15
Distribution pattern: 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
Derived failure modes
-
Unknown
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.