Qualigen Recalls FastPack Total PSA Immunoassay Kits Due to Manufacturing Defect
Qualigen Inc is recalling 182 units of the FastPack Total PSA Immunoassay 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. The hazard involves a manufacturing defect that may lead to inaccurate diagnostic results (lower than expected), which poses a risk of harm to patients through potential mismanagement of prostate cancer, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Qualigen Inc is recalling 182 units of the FastPack Total PSA Immunoassay. This product is a chemiluminescence assay used for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma. The recall is limited to Catalog Number 25000040, Lot Number 1309038-10P, with an expiration date of 6/26/2013.
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 should stop using the affected units and contact Qualigen Inc for further instructions on how to return or dispose of the product.
The recalled product
- Product
- FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid…
- Manufacturer
- Qualigen Inc
- Affected units
- 182
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)
- Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013.
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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