RegWardenFDA facility compliance records
Company

QUALIGEN, INC.

5 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2013: 1 recalls; 2017: 1 recalls; 2019: 1 recalls; 2024: 2 recalls1’13’14’15’161’17’181’19’20’21’22’232’24’25’26
  • Recalls (5)

Registered facilities (1)

Recalls & enforcement

  • Class IIIOngoing2024-12-03
    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 Q…
  • Class IIOngoing2024-08-26
    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.
  • Class IITerminated2019-11-06
    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.
  • Class IITerminated2017-07-07
    Specific lots have been reported to produce falsely lower than expected results for Vitamin D
  • Class IITerminated2013-11-08
    Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “QUALIGEN, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9040045-qualigen-inc/

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