Qualigen Inc: Medical Device Recall in 2013 - (Recall #: Z-0547-2014)

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 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. The FastPack Total PSA 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-0547-2014

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: 182

Code Information:

Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013.

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