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All product recalls associated with Qualigen Inc.
Total Recalls
5
Past Year
0
Class I (Serious)
0
Most Recent
Dec 2024
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected lots: Lot Number: 2408018-1, 2409015-1, and 2409015-2. The likelihood of patient harm is expected to be low as routine Quality Control should detect kits that are impacted by signal deterioration due to age.
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.
The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in human serum and plasma.
The recall was initiated after the firm investigation of customer complaints of falsely elevated results determined the product was not meeting product performance expectations.
Kits may produce results that are falsely elevated.