Device Recall FastPack Total PSA Immunoassay

Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013.

Immunology and Microbiology Devices

2

No

US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.

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.