FDAFDA · Food and drugs·Recall number Z-3112-2017
Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
Published September 13, 2017 · Recall initiated: July 7, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Specific lots have been reported to produce falsely lower than expected results for Vitamin D
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Qualigen Inc
- Distributor
- Worldwide Distribution: US (Nationwide) and to countries of: Germany, Switzerland, turkey and UAE.
- Lot
- Lot numbers: 1701033-3P, 1701033-4P, 1701033-5P, and 1701033-6P
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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