Device product
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.
Z-0550-2014
Product summary
- Firm
- Qualigen Inc
- Event
- Event 66842
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6
- Official record key
device-enforcement:Z-0550-2014
Official wording
Reason: Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
Code information: Testosterone. Catalog Number 25000059. Lot Number 1309062-2P.Exp Date: 7/9/2014
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