# FDA recall Z-1672-2020

> **Qualigen Inc** · Class II · device recall initiated 2019-11-06.

## 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.

## Distribution

US Nationwide distribution in the states of AL, AK, CA, HI, and TX.

## Key facts

- **Recall number:** Z-1672-2020
- **Recalling firm:** Qualigen Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-06
- **Report date:** 2020-04-15
- **Termination date:** 2020-09-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carlsbad, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1672-2020

## Citation

> AI Analytics. FDA recall Z-1672-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-1672-2020. Source: US FDA. Licensed CC0.

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