Device product
Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process.
Z-0306-2018
Product summary
- Event
- Event 77107
- Status
- Terminated
- Classification
- Class II
- Quantity
- 534 kits
- Official record key
device-enforcement:Z-0306-2018
Official wording
Reason: Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit might not perform correctly and so potentially yield false positive samples.
Code information: Lot: TS 2076
Distribution pattern: MN, NE, TX
Derived failure modes
-
Unknown
Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit might not perform correctly and so potentially yield false positive samples.