Medical Device Recall: FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Qualigen Inc · August 26, 2024
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
States Affected
AK, AL, GA, IA, KS, MA, MN, MS, MT, NC, NE, NV, NY, OH, OK, PA, SC, SD, TX, UT, VT, WA, WI, WV, WY
Quantity Affected
60
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0022-2025
Status: ongoing
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