FDA Device recall Z-1672-2020
The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended…
- FDA Device
- Class II
- terminated
- Published 2020-04-15
On 2020-04-15 the FDA classified a Class II recall of The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended… by Qualigen, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1672-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-06 |
| Published | 2020-04-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Qualigen |
| Distribution | US |
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
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.
Identifiers
| code_info | 1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Qualigen
- The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and pl…
FDA Device · Class III · 2025-01-15 · Qualigen - FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
FDA Device · Class II · 2024-10-16 · Qualigen - Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
FDA Device · Class II · 2017-09-13 · Qualigen - FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic part…
FDA Device · Class II · 2013-12-25 · Qualigen - FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The FastPack Vitamin D…
FDA Device · Class II · 2013-12-25 · Qualigen
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1672-2020%22
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