Device product
is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.
Z-2922-2018
Product summary
- Event
- Event 80684
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4
- Official record key
device-enforcement:Z-2922-2018
Official wording
Reason: Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Code information: Lot #'s: TS 1740 (kit) and TS 1743 (PC)
Distribution pattern: MN
Derived failure modes
-
Labeling or packaging
Incorrectly labeled