Z-1672-2020 Class II Terminated
FDA device recall Z-1672-2020 was initiated by Qualigen Inc on November 6, 2019 and is designated Class II. 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 plasm… The recall status is terminated (terminated September 23, 2020). Affected quantity: 24 Kits (30 test packs each) 720 tests.
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2020
- Initiation Date
- November 6, 2019
- Termination Date
- September 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 Kits (30 test packs each) 720 tests
Product Description
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.
Distribution Pattern
US Nationwide distribution in the states of AL, AK, CA, HI, and TX.
Code Information
1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P