Device 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 use with the FastPack System.
Z-0549-2014
Product summary
- Firm
- Qualigen Inc
- Event
- Event 66842
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17
- Official record key
device-enforcement:Z-0549-2014
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 25000043. Lot Number 1310028-2P.Exp Date: 4/10/2014
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