FDA-Device2017-09-13Class II

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

Qualigen Inc
Hazard

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

Sold states
Worldwide Distribution: US (Nationwide) and to countries of: Germany, Switzerland, turkey and UAE.
Affected count
493 units
Manufactured in
2042 Corte Del Nogal, N/A, Carlsbad, CA, United States
Products
Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit

Official notice

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

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