Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection Recalled by Euro Diagnostica AB Due to Incorrectly labeled Manufactured by DiaSorin, The correct term...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Euro Diagnostica AB directly.
Affected Products
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
Quantity: 6
Why Was This Recalled?
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Where Was This Sold?
This product was distributed to 1 state: MN
About Euro Diagnostica AB
Euro Diagnostica AB has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report