Device product
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess of anti-cardiolipin IgG autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders
Z-2920-2018
Product summary
- Event
- Event 80684
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6
- Official record key
device-enforcement:Z-2920-2018
Official wording
Reason: Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Code information: Lot #'s: TS 2783 (kit) and TS 2787 (PC)
Distribution pattern: MN
Derived failure modes
-
Labeling or packaging
Incorrectly labeled