Device product
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.
Z-0547-2014
Product summary
- Firm
- Qualigen Inc
- Event
- Event 66842
- Status
- Terminated
- Classification
- Class II
- Quantity
- 182
- Official record key
device-enforcement:Z-0547-2014
Official wording
Reason: Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
Code information: Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013.
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