Qualigen Recalls FastPack Testosterone Immunoassay Kits Due to Manufacturing Defect
Qualigen Inc is recalling 18 FastPack Testosterone Immunoassay kits because a manufacturing defect may cause lower than expected test results.
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, and the hazard involves inaccurate diagnostic results (lower than expected) due to a manufacturing defect, which fits the criteria for moderate severity involving potential misdiagnosis without reported serious injury.
Plain-English summary
Qualigen Inc is voluntarily recalling 18 units of the FastPack Testosterone Immunoassay. This product is a chemiluminescence assay used for the in vitro quantitative determination of total testosterone in human serum and plasma. The recall is limited to Catalog Number 25000041, Lot Number 1310019-3P, with an expiration date of 9/22/2014.
The recall was initiated because the kits may cause lower than expected results due to a manufacturing defect. The affected units were distributed in the United States to the states of Alabama, California, Kansas, Kentucky, Indiana, Massachusetts, North Carolina, New York, Nevada, Oklahoma, South Carolina, Tennessee, Texas, Utah, Virginia, and Washington.
Healthcare facilities and laboratories should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be removed from use and returned to Qualigen Inc or the distributor as directed.
The recalled product
- Product
- FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended str
- Manufacturer
- Qualigen Inc
- Affected units
- 18
Distribution
Part of a larger recall action
This product is one of 4 recalled by Qualigen Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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