Class II — Qualigen Inc
| Recalling firm | QUALIGEN, INC. |
|---|---|
| Registered facility | QUALIGEN, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. |
| 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 strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack Testo Immunoassay is designed for use with the FastPack System. |
| Quantity | 18 |
| Distribution | US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA. |
| Initiated | 2013-11-08 |
| Classified | 2013-12-19 |
| Terminated | 2014-09-18 |
| Recall number | Z-0548-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Qualigen Inc (Z-0548-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66842/
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