Reported Dec 25, 2013 · Terminated
FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo…
Qualigen Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Qualigen Inc · 2042 Corte del Nogal · Carlsbad, CA · 92011-1438
Is this the product you have?
- 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 strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack Testo Immunoassay is designed for use with the FastPack System.
- Lot codes and dates
- Testosterone. Catalog Number 25000041
- Lot Number 1310019-3P Exp Date9/22/2014
- Amount recalled
- 18
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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