PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: September 13, 2017 Initiated: July 7, 2017 #Z-3112-2017

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

Details

Recalling Firm
Qualigen Inc
Units Affected
493 units
Distribution
Worldwide Distribution: US (Nationwide) and to countries of: Germany, Switzerland, turkey and UAE.
Location
Carlsbad, CA

Frequently Asked Questions

What product was recalled?
Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit. Recalled by Qualigen Inc. Units affected: 493 units.
Why was this product recalled?
Specific lots have been reported to produce falsely lower than expected results for Vitamin D
Which agency issued this recall?
This recall was issued by the FDA Devices on September 13, 2017. Severity: Moderate. Recall number: Z-3112-2017.