Device product
AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers.
Z-0671-2019
Product summary
- Event
- Event 81597
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29645 units
- Official record key
device-enforcement:Z-0671-2019
Official wording
Reason: Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays
Code information: all lots
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays