Device 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 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.
Z-0548-2014
Product summary
- Firm
- Qualigen Inc
- Event
- Event 66842
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18
- Official record key
device-enforcement:Z-0548-2014
Official wording
Reason: Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
Code information: Testosterone. Catalog Number 25000041. Lot Number 1310019-3P Exp Date: 9/22/2014
Distribution pattern: US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
Derived failure modes
-
Manufacturing or process control
manufacturing defect