Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear Recalled by Euro Diagnostica AB Due to Euro Diagnostica has identified a deviation in one...
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
Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process.
Quantity: 534 kits
Why Was This Recalled?
Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit might not perform correctly and so potentially yield false positive samples.
Where Was This Sold?
This product was distributed to 3 states: MN, NE, TX
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