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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.

FDA Recall Z-2921-2018 · Posted 2018-08-23

Recalling FirmEuro Diagnostica AB
Recall StatusTerminated
Product CodeMID
Date Initiated2016-10-21
Date Terminated2019-11-05
Product Quantity6

Reason for Recall

Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.

Firm Action

none

Root Cause

Error in labeling

Distribution Pattern

MN

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K001574DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600Axis-Shield · 2000-06-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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