Device 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
Z-1672-2020
Product summary
- Firm
- Qualigen Inc
- Event
- Event 85134
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24 Kits (30 test packs each) 720 tests
- Official record key
device-enforcement:Z-1672-2020
Official wording
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.
Code information: 1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P
Distribution pattern: US Nationwide distribution in the states of AL, AK, CA, HI, and TX.
Derived failure modes
-
Unknown
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.