FDAFDA · Food and drugs·Recall number Z-0548-2014
FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack Testo 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
- Testosterone. Catalog Number 25000041. Lot Number 1310019-3P Exp Date: 9/22/2014
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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