Qualigen recalls
Qualigen appears in 8 official U.S. recall notices indexed by RecallRadar, most recently on 2025-01-15.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 8 |
|---|---|
| Published | 2013-12-25 to 2025-01-15 |
| By agency | FDA Device (8) |
| By classification | Class II (7), Class III (1) |
| By status | terminated (6), ongoing (2) |
| Distribution named in notices | AK, AL, AR, CA, CO, FL, GA, IA, IL, IN, KS, KY, MA, MN, MO, MS, MT, NC, NE, NV, NY, OH, OK, PA, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and pl…
FDA Device · Class III · 2025-01-15 · Qualigen
Reason: 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… - FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
FDA Device · Class II · 2024-10-16 · Qualigen
Reason: 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 FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended…
FDA Device · Class II · 2020-04-15 · Qualigen
Reason: 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. - Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
FDA Device · Class II · 2017-09-13 · Qualigen
Reason: Specific lots have been reported to produce falsely lower than expected results for Vitamin D - FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic part…
FDA Device · Class II · 2013-12-25 · Qualigen
Reason: Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. - FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The FastPack Vitamin D…
FDA Device · Class II · 2013-12-25 · Qualigen
Reason: Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. - FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagne…
FDA Device · Class II · 2013-12-25 · Qualigen
Reason: Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. - FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic p…
FDA Device · Class II · 2013-12-25 · Qualigen
Reason: Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.