Qualigen Recalls FastPack Immunoassay Kits Due to Manufacturing Defect
Qualigen Inc is recalling six FastPack immunoassay kits because a manufacturing defect may cause lower than expected test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (inaccurate diagnostic results) where no specific injuries or illnesses have been reported, fitting the criteria for a High severity score.
Plain-English summary
Qualigen Inc is recalling six units of FastPack immunoassay kits, including the Free T4, Vitamin D, and Total PSA assays. The recall was initiated because a manufacturing defect may cause the kits to produce lower than expected results.
The affected products 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. The specific lot information provided is for the Testosterone assay, Catalog Number 25000059, Lot Number 1309062-2P, with an expiration date of 7/9/2014.
Healthcare providers and laboratories should stop using the affected kits and contact Qualigen Inc for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The FastPack Vitamin D Immunoassay is intended for the quantitative determination of FastPack Total PSA Immunoassay Chemilunescence assay for the…
- Manufacturer
- Qualigen Inc
- Affected units
- 6
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 25000059. Lot Number 1309062-2P.Exp Date: 7/9/2014
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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