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 autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sj¿gren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.
Quantity: 4
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