Qualigen Inc

Complete recall history across all FDA and CPSC categories — 8 total recalls

Qualigen Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (8)

FDA medical device enforcement actions by Qualigen Inc

Date Product Reason Class
Dec 3, 2024 The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is ... Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were ... Class III
Aug 26, 2024 FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the F... Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode li... Class II
Nov 6, 2019 The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitati... The chemiluminescent immunoassay has been noted to have higher than expected ... Class II
Jul 7, 2017 Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog nu... Specific lots have been reported to produce falsely lower than expected resul... Class II
Nov 8, 2013 FastPack Free T4 Immunoassay Chemilunescence assay for the determination of... Qualigen initiated this recall because the FastPack kit may cause lower than ... Class II
Nov 8, 2013 FastPack Total PSA Immunoassay Chemilunescence assay for the determination ... Qualigen initiated this recall because the FastPack kit may cause lower than ... Class II
Nov 8, 2013 FastPack Testosterone Immunoassay Chemilunescence assay for the determinati... Qualigen initiated this recall because the FastPack kit may cause lower than ... Class II
Nov 8, 2013 FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescen... Qualigen initiated this recall because the FastPack kit may cause lower than ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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