Recall Z-2921-2018— Euro Diagnostica AB
Class III · Terminated
Class III FDA medical device recall by Euro Diagnostica AB, initiated 2016-10-21, terminated 2019-11-05. It names one FDA 510(k) clearance: K001574. 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 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..
- Recalling firm
- Euro Diagnostica AB
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-10-21
- Terminated
- 2019-11-05
- Firm location
- Malmo, Sweden
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Data sourced from openFDA. This site is unofficial and independent of the FDA.