FDA-Device2018-01-10Class II
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.
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.
Sold states
MN, NE, TX
Affected count
534 kits
Manufactured in
Box 50117, Lundavagen 151, Malmo, N/A, Sweden
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0306-2018Don't want to check this manually?
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