FDA Recall
Terminated
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 anti-cardiolipin IgM 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.
Recall: Z-2921-2018
·
Initiated October 21, 2016
Recall
- Recall Number
- Z-2921-2018
- Event Number
- 80684
- Firm
- Euro Diagnostica AB
- FEI Number
- 3007610287
- Product Code
- MID
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- October 21, 2016
- Posted
- August 23, 2018
- Terminated
- November 5, 2019
- Address
- Box 50117, Lundavagen 151, Malmo Sweden
Description
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 anti-cardiolipin IgM 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.
Reason
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Action
none
Distribution
MN
Quantity
6