Device product
Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
Z-3112-2017
Product summary
- Firm
- Qualigen Inc
- Event
- Event 77726
- Status
- Terminated
- Classification
- Class II
- Quantity
- 493 units
- Official record key
device-enforcement:Z-3112-2017
Official wording
Reason: Specific lots have been reported to produce falsely lower than expected results for Vitamin D
Code information: Lot numbers: 1701033-3P, 1701033-4P, 1701033-5P, and 1701033-6P
Distribution pattern: Worldwide Distribution: US (Nationwide) and to countries of: Germany, Switzerland, turkey and UAE.
Derived failure modes
-
Unknown
Specific lots have been reported to produce falsely lower than expected results for Vitamin D