Recall Z-3112-2017— Qualigen Inc

Name: FDA recall Z-3112-2017
Creator: U.S. Food and Drug Administration
Published: 2017-07-07

Class II · Terminated

Class II FDA medical device recall by Qualigen Inc, initiated 2017-07-07, terminated 2018-10-22. It names one FDA 510(k) clearance: K123983. Product: Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit. Reason: Specific lots have been reported to produce falsely lower than expected results for Vitamin D.

Recalling firm: Qualigen Inc
Classification: Class II
Status: Terminated
Initiated: 2017-07-07
Terminated: 2018-10-22
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K123983 — FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERSQualigen, Inc.·cleared 2013-07-03

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

Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit

Reason for recall

Specific lots have been reported to produce falsely lower than expected results for Vitamin D

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