Class II — Qualigen Inc
| Recalling firm | QUALIGEN, INC. |
|---|---|
| Registered facility | QUALIGEN, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Specific lots have been reported to produce falsely lower than expected results for Vitamin D |
| Product | Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit |
| Quantity | 493 units |
| Distribution | Worldwide Distribution: US (Nationwide) and to countries of: Germany, Switzerland, turkey and UAE. |
| Initiated | 2017-07-07 |
| Classified | 2017-09-07 |
| Terminated | 2018-10-22 |
| Recall number | Z-3112-2017 |
| 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-3112-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77726/
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