Device product
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sj¿gren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.
Z-2919-2018
Product summary
- Event
- Event 80684
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4
- Official record key
device-enforcement:Z-2919-2018
Official wording
Reason: Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Code information: Lot #'s: TS2725 (kit) and TS 2733 (PC)
Distribution pattern: MN
Derived failure modes
-
Labeling or packaging
Incorrectly labeled