Recall record at a glance
| Official record | Z-1672-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Qualigen Inc. |
| Report date | Apr 15, 2020 |
| Recall initiation date | Nov 6, 2019 |
| Quantity | 24 Kits (30 test packs each) 720 tests |
| Location | Carlsbad, CA, United States |
Official 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
Why the product was 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.
Distribution information
US Nationwide distribution in the states of AL, AK, CA, HI, and TX.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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