Class II — Qualigen Inc
| Recalling firm | QUALIGEN, INC. |
|---|---|
| Registered facility | QUALIGEN, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in human serum and plasma. |
| Product | The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack System. The FastPack IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. Each Kit Contains 30 FastPack IP SHBG Immunoassays 1 Calibrator 1 x 3 mL Vial 1 Control 1 1 x 3 mL Vial 1 Control 2 1 x 3 mL Vials 32 Sample Diluent 0.9 mL Vials REF 25000081 IVD CE 1908038-1P 2020-02-22 (01) 20816467020345 … |
| Quantity | 24 Kits (30 test packs each) 720 tests |
| Distribution | US Nationwide distribution in the states of AL, AK, CA, HI, and TX. |
| Initiated | 2019-11-06 |
| Classified | 2020-04-06 |
| Terminated | 2020-09-23 |
| Recall number | Z-1672-2020 |
| 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-1672-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85134/
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