Qualigen Inc: Medical Device Recall in 2020 - (Recall #: Z-1672-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: November 6, 2019

Date Posted: April 15, 2020

Recall Number: Z-1672-2020

Event ID: 85134

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.

Status: Terminated

Product Quantity: 24 Kits (30 test packs each) 720 tests

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.

Voluntary or Mandated:

Voluntary: Firm initiated