Z-3112-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 13, 2017
- Initiation Date
- July 7, 2017
- Termination Date
- October 22, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 493 units
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
Distribution Pattern
Worldwide Distribution: US (Nationwide) and to countries of: Germany, Switzerland, turkey and UAE.
Code Information
Lot numbers: 1701033-3P, 1701033-4P, 1701033-5P, and 1701033-6P