Reported Jan 10, 2018 · Terminated
Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test…
Euro Diagnostica AB
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Euro Diagnostica AB · Box 50117 · Malmo, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- LotTS 2076
- Amount recalled
- 534 kits
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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