Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Qualigen with 15 510(k) clearances and 8 device recalls. The most recent is a device recall dated Dec 3, 2024: The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the qua….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Dec 3, 2024 | The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plaClass III · Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. | Device recalls |
| Aug 26, 2024 | FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System AnalyzerClass II · Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may all | Device recalls |
| Nov 6, 2019 | The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intendClass II · The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quan | Device recalls |
| Jan 29, 2019 | FastPack IP Sex Hormone Binding Globulin ImmunoassayK182521 · CDZ | 510(k) clearances |
| Jul 7, 2017 | Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kitClass II · Specific lots have been reported to produce falsely lower than expected results for Vitamin D | Device recalls |
| Jan 7, 2015 | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification KitK141689 · DCK | 510(k) clearances |
| Nov 8, 2013 | FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The FastPack VitClass II · Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing def | Device recalls |
| Nov 8, 2013 | FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramClass II · Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing def | Device recalls |
| Nov 8, 2013 | FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetClass II · Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing def | Device recalls |
| Nov 8, 2013 | FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetiClass II · Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing def | Device recalls |
| Jul 3, 2013 | FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERSK123983 · MRG | 510(k) clearances |
| Mar 8, 2013 | FASTPACK CONTROL KITK123725 · JJY | 510(k) clearances |
| Feb 18, 2011 | FASTPACK TESTO IMMUNOASSAYK101388 · CDZ | 510(k) clearances |
| Aug 13, 2010 | FASTPACK TSH IMMUNOASSAYK101390 · JLW | 510(k) clearances |
| Dec 6, 2007 | FASTPACK HCG IMMUNOASSAYK072264 · JHI | 510(k) clearances |
| Apr 2, 2007 | FASTPACK TOTAL PSA METHOD VERIFICATION KITK062957 · JJX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
