Z-0550-2014 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
- 6
Product Description
FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The FastPack Vitamin D Immunoassay is intended for the quantitative determination of 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 in the management of patients with prostate cancer.
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 25000059. Lot Number 1309062-2P.Exp Date: 7/9/2014