Z-0547-2014 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
- 182
Product Description
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. The FastPack Total PSA 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
Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013.