Qualigen recalls

2 official recalls and safety alerts involving Qualigen since 2024-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Qualigen or the relevant agency.

1. 2025-01-15
2. US
   Drugs & medicalClass III

   Qualigen Inc recalls The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and…

   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…

   FDA · DeviceQualigen IncDistribution was made to AR, CA, CO, FL, IL, IN, MA, MO, NC, NY, OH, OK, TN,…Official notice →
3. 2024-10-16
4. US
   Drugs & medicalClass II

   Qualigen Inc recalls 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.

   FDA · DeviceQualigen IncUS: TX, MS, NY, OH, MT, WA, PA, MN, SC, GA, NC, NV, WY, AK, SD, KS, NE, VT,…Official notice →