FDAFDA · Food and drugs·Recall number Z-0547-2014
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.
Published December 25, 2013 · Recall initiated: November 8, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Qualigen Inc
- Distributor
- US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
- Lot
- Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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