Qualigen Inc Recalls
2 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (2)
- Class III
December 3, 2024
The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks.
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.
- Class II
August 26, 2024
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
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.
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.