CLASS II Device recall · Reported 15 Apr 2020 · FDA Enforcement Report
The FastPack System Comlete Immunoassay Kit Immunoassay recalled
Qualigen is recalling The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement, distributed nationwide in the US. The recall was initiated on 6 Nov 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1672-2020
- FDA event ID
- 85134
- Recalling firm
- Qualigen, Carlsbad, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Nov 2019
- FDA classified
- 6 Apr 2020
- Reported
- 15 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Test Kits & Diagnostics
Timeline
| 6 Nov 2019 | Recall initiated by company | |
| 6 Apr 2020 | Classified by FDA | +152 days |
| 15 Apr 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution in the states of AL, AK, CA, HI, and TX.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P
Where was it sold?
US Nationwide distribution in the states of AL, AK, CA, HI, and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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