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Euro Diagnostica AB recalls Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test re
Recalled January 10, 2018 · FDA recall Z-0306-2018 · Euro Diagnostica AB
Hazard
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. · FDA Class II
Units
534 kits
Sold at
MN, NE, TX
Description
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.
Product
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.
Manufacturer(s)
Euro Diagnostica AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →