Qualigen Recalls FastPack Free T4 Immunoassay Kits Due to Manufacturing Defect
Qualigen Inc is recalling 17 units of the FastPack Free T4 Immunoassay 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 source text describes a manufacturing defect causing inaccurate results without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity recall.
Plain-English summary
Qualigen Inc is recalling 17 units of the FastPack Free T4 Immunoassay. This is a chemiluminescence assay used for the in vitro quantitative determination of Free T4 (FT4) in human serum. The affected product is identified by Catalog Number 25000043, Lot Number 1310028-2P, and an expiration date of 4/10/2014.
The recall was initiated because the kit 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 that have received this product should stop using the affected kits and contact Qualigen Inc for further instructions. Consumers should not use the product and should contact their healthcare provider if they have questions regarding recent test results.
The recalled product
- Product
- FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 Immunoassay is designed for u
- Manufacturer
- Qualigen Inc
- Affected units
- 17
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)
- Testosterone. Catalog Number 25000043. Lot Number 1310028-2P.Exp Date: 4/10/2014
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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