Reported Aug 29, 2018 · Terminated
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies…
Euro Diagnostica AB
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Euro Diagnostica AB · Box 50117 · Malmo · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- Lot #'s: TS 2819 (kit) and TS 2841 (PC)
- Amount recalled
- 6
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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