FDA Enforcement
Class III
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 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
Recall: Z-2920-2018
·
Reported August 29, 2018
Enforcement
- Recall Number
- Z-2920-2018
- Event ID
- 80684
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Euro Diagnostica AB
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 29, 2018
- Initiation Date
- October 21, 2016
- Classification Date
- August 23, 2018
- Termination Date
- November 5, 2019
- Address
- Box 50117, Lundavagen 151, Malmo, N/A, 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 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
Reason
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Code Info
Lot #'s: TS 2783 (kit) and TS 2787 (PC)
Distribution
MN
Quantity
6