PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 25, 2013 Initiated: November 8, 2013 #Z-0548-2014

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.

Details

Recalling Firm
Qualigen Inc
Units Affected
18
Distribution
US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
Location
Carlsbad, CA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Qualigen Inc. Units affected: 18.
Why was this product recalled? ▼
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 25, 2013. Severity: Moderate. Recall number: Z-0548-2014.

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