FDAFDA · Food and drugs·Recall number Z-0550-2014
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.
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
- Testosterone. Catalog Number 25000059. Lot Number 1309062-2P.Exp Date: 7/9/2014
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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