Z-0548-2014 Class II Terminated
FDA device recall Z-0548-2014 was initiated by Qualigen Inc on November 8, 2013 and is designated Class II. Reason for recall: Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. The recall status is terminated (terminated September 18, 2014). Affected quantity: 18.
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2013
- Initiation Date
- November 8, 2013
- Termination Date
- September 18, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18
Product Description
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.
Reason for Recall
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
Distribution Pattern
US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
Code Information
Testosterone. Catalog Number 25000041. Lot Number 1310019-3P Exp Date: 9/22/2014