The Recall Desk

Manufacturer

Qualigen Inc

8 recalls in our database name Qualigen Inc as the manufacturing or recalling firm.

What the numbers show

Total
8
Critical
0
Severe
0
Most recent
2025-01-15

Of the 8 recalls from Qualigen Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–8 of 8

  • ModerateFDA (Devices)·Z-0805-2025·2025-01-15

    Diagnostic Immunoassay Kits Recalled for Incorrect Expiration Date Labeling

    Qualigen is recalling 426 units of FastPack SHBG diagnostic kits due to incorrect expiration date labels on three lots. The kits were distributed to 15 U.S. states.

    Product
    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.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0022-2025·2024-10-16

    FastPack TSH Calibrator Kit Recalled Due to Incorrect Barcode

    Qualigen Inc is recalling the FastPack TSH Calibrator Kit due to an incorrect barcode linked to incorrect information. The barcode defect may allow successful system calibration, but TSH test results obtained could be higher than expected.

    Product
    FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Devices)·Z-1672-2020·2020-04-15

    Qualigen FastPack SHBG Immunoassay Kit Recalled for Inaccurate Results

    Qualigen Inc is recalling FastPack System Complete Immunoassay Kits for SHBG because they may produce higher than expected results, leading to inaccurate quantitative determinations.

    Product
    The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack System. The FastPack IP SHB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3112-2017·2017-09-13

    Qualigen Vitamin D Immunoassay Kit Recalled for Inaccurate Test Results

    Qualigen Inc is recalling specific lots of its Vitamin D Complete Immunoassay Kit because they may produce falsely low results.

    Product
    Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0550-2014·2013-12-25

    Qualigen Recalls FastPack Immunoassay Kits Due to Manufacturing Defect

    Qualigen Inc is recalling six FastPack immunoassay kits because a manufacturing defect may cause lower than expected test results.

    Product
    FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The FastPack Vitamin D Immunoassay is intended for the quantitative determination of FastPack Total PSA Immunoassay Chemilunescence assay for the determinat
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0547-2014·2013-12-25

    Qualigen Recalls FastPack Total PSA Immunoassay Kits Due to Manufacturing Defect

    Qualigen Inc is recalling 182 units of the FastPack Total PSA Immunoassay because a manufacturing defect may cause lower than expected test results.

    Product
    FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid i
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0549-2014·2013-12-25

    Qualigen Recalls FastPack Free T4 Immunoassay Kits Due to Manufacturing Defect

    Qualigen Inc is recalling 17 units of the FastPack Free T4 Immunoassay because a manufacturing defect may cause lower than expected test results.

    Product
    FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 Immunoassay is designed for u
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0548-2014·2013-12-25

    Qualigen Recalls FastPack Testosterone Immunoassay Kits Due to Manufacturing Defect

    Qualigen Inc is recalling 18 FastPack Testosterone Immunoassay kits because a manufacturing defect may cause lower than expected test results.

    Product
    FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended str
    Category
    Medical Device
    Distribution
    16 states