The FastPack System Comlete Immunoassay Kit Immunoassay for the… — Class II medical device recall Z-1672-2020
Terminated recall by Qualigen Inc, reported 2020-04-15, distributed nationwide. The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inacc
| Recall number | Z-1672-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qualigen Inc, Carlsbad, CA, United States |
| Recall initiated | 2019-11-06 |
| Classified | 2020-04-06 |
| Reported by FDA | 2020-04-15 |
| Terminated | 2020-09-23 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 20816467020345 |
| Model numbers | 1908038-1P, 25000081IVD |
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 (17) 200222 (10) 1908038-1P
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.