Qualigen Inc: Medical Device Recall in 2013 - (Recall #: Z-0550-2014)

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 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.

Product Classification:

Class II

Date Initiated: November 8, 2013

Date Posted: December 25, 2013

Recall Number: Z-0550-2014

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: 6

Code Information:

Testosterone. Catalog Number 25000059. Lot Number 1309062-2P.Exp Date: 7/9/2014

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