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

Recall date

July 7, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3112-2017

FDA classification

Class II

Brand / firm

Qualigen Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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