Qualigen recalls

Qualigen has 8 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 15 Jan 2025. 2 are still ongoing. The most frequent reason is potency & assay.

Total recalls8since 2013

Last 12 months0reported

Class I00% of total

Ongoing2latest 15 Jan 2025

Recalls per month, last 24 months

click a bar for that month

1Oct '24 0 0 1Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 7 88%Class III 1 13%

Why qualigen is recalled

Potency & Assay788%
Labeling Errors113%

Product types

Test Kits & Diagnostics8100%

By year

2025113%
2024113%
2020113%
2017113%
2013450%

Ongoing qualigen recalls

2 active

Reported	Class	Recall	Company	Reason	Where
15 Jan 2025Device	CLASS III	The FastPack IP Sex Hormone Binding Globulin Immunoassay recalled	Qualigen	Potency & Assay	15 states
16 Oct 2024Device	CLASS II	FastPack TSH Calibrator Kit recalled by Qualigen	Qualigen	Potency & Assay	25 states

All qualigen recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
15 Jan 2025Device	CLASS III	The FastPack IP Sex Hormone Binding Globulin Immunoassay recalled	Qualigen	Potency & Assay	15 states
16 Oct 2024Device	CLASS II	FastPack TSH Calibrator Kit recalled by Qualigen	Qualigen	Potency & Assay	25 states
15 Apr 2020Device	CLASS II	The FastPack System Comlete Immunoassay Kit Immunoassay recalled	Qualigen	Labeling Errors	Nationwide
13 Sep 2017Device	CLASS II	Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit recalled	Qualigen	Potency & Assay	Nationwide
25 Dec 2013Device	CLASS II	FastPack Free T4 Immunoassay Chemilunescence assay recalled by Qualigen	Qualigen	Potency & Assay	16 states
25 Dec 2013Device	CLASS II	FastPack Total PSA Immunoassay Chemilunescence assay recalled	Qualigen	Potency & Assay	16 states
25 Dec 2013Device	CLASS II	FastPack Testosterone Immunoassay Chemilunescence assay recalled	Qualigen	Potency & Assay	16 states
25 Dec 2013Device	CLASS II	FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay recalled	Qualigen	Potency & Assay	16 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.