Class II — Qualigen Inc
| Recalling firm | QUALIGEN, INC. |
|---|---|
| Registered facility | QUALIGEN, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtained could be higher than expected. |
| Product | FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer |
| Quantity | 60 |
| Distribution | US: TX, MS, NY, OH, MT, WA, PA, MN, SC, GA, NC, NV, WY, AK, SD, KS, NE, VT, AL, MA, OK, UT, WI, IA, WV. OUS: Germany, Switzerland |
| Initiated | 2024-08-26 |
| Classified | 2024-10-08 |
| Recall number | Z-0022-2025 |
| 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-0022-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95326/
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