Qualigen Recalls
8 recalls on record · December 25, 2013 to January 15, 2025 · Medical Devices
Recalls by year
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25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 15, 2025Medical DevicesFDA
Qualigen Inc recalls The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in
Hazard: 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.
October 16, 2024Medical DevicesFDA
Qualigen Inc recalls FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP
Hazard: 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.
April 15, 2020Medical DevicesFDA
Qualigen Inc recalls The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescen
Hazard: 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.
September 13, 2017Medical DevicesFDA
Qualigen Inc recalls Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
Hazard: Specific lots have been reported to produce falsely lower than expected results for Vitamin D
December 25, 2013Medical DevicesFDA
Qualigen Inc recalls FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D
Hazard: Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
December 25, 2013Medical DevicesFDA
Qualigen Inc recalls FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoas
Hazard: Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
December 25, 2013Medical DevicesFDA
Qualigen Inc recalls FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Im
Hazard: Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
December 25, 2013Medical DevicesFDA
Qualigen Inc recalls FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoa
Hazard: Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.