Qualigen Inc: Medical Device Recall in 2013 - (Recall #: Z-0548-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 8, 2013

Date Posted: December 25, 2013

Recall Number: Z-0548-2014

Event ID: 66842

Reason for Recall:

Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.

Status: Terminated

Product Quantity: 18

Code Information:

Testosterone. Catalog Number 25000041. Lot Number 1310019-3P Exp Date: 9/22/2014

Distribution Pattern:

US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.

Voluntary or Mandated:

Voluntary: Firm initiated