Qualigen Inc: FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer

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.

Details from the source

Reason for recall: 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. Distribution: 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 Quantity: 60 Lot/code info: UDI-DI: 00816467020099, Lot: 2405017-1, Expiration: 2025-05-15

UPC codes

00816467020099

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.