Recall Z-0549-2014— Qualigen Inc

Name: FDA recall Z-0549-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-08

Class II · Terminated

Class II FDA medical device recall by Qualigen Inc, initiated 2013-11-08, terminated 2014-09-18. It names one FDA 510(k) clearance: K030329. Product: FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 Immunoassay is designed for use with the FastPack System.. Reason: Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect..

Recalling firm: Qualigen Inc
Classification: Class II
Status: Terminated
Initiated: 2013-11-08
Terminated: 2014-09-18
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K030329 — FASTPACK FREE T4 IMMUNOASSAYQualigen, Inc.·cleared 2003-07-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.