FDA recall Z-3112-2017

Product

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

Distribution

Worldwide Distribution: US (Nationwide) and to countries of: Germany, Switzerland, turkey and UAE.

Key facts

Status

Terminated

Initiation date

2017-07-07

Report date

2017-09-13

Termination date

2018-10-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Carlsbad, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3112-2017