Z-0549-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2013
- Initiation Date
- November 8, 2013
- Termination Date
- September 18, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17
Product Description
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.
Reason for Recall
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
Distribution Pattern
US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
Code Information
Testosterone. Catalog Number 25000043. Lot Number 1310028-2P.Exp Date: 4/10/2014