Qualigen FastPack SHBG Immunoassay Kit Recalled for Inaccurate Results
Qualigen Inc is recalling FastPack System Complete Immunoassay Kits for SHBG because they may produce higher than expected results, leading to inaccurate quantitative determinations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is limited to inaccurate test results, which fits the criteria for a moderate severity score.
Plain-English summary
Qualigen Inc is recalling the FastPack System Complete Immunoassay Kit for the Quantitative Measurement of SHBG (Sex Hormone Binding Globulin). The recall involves 24 kits, containing a total of 720 tests, which were distributed nationwide in the states of Alabama, Alaska, California, Hawaii, and Texas.
The recall was initiated because the chemiluminescent immunoassay has been noted to produce higher than expected results. This defect may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in human serum and plasma. The assay is intended for use as an aid in the diagnosis of androgen disorders.
Healthcare facilities and laboratories that possess these kits should stop using them and contact Qualigen Inc for instructions on how to return the product. The recall is classified as Class II by the FDA.
The recalled product
- 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 SHB
- Manufacturer
- Qualigen Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P
Distribution
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