FDAFDA · Food and drugs·Recall number Z-0306-2018
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.
Published January 10, 2018 · Recall initiated: February 14, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Euro Diagnostica AB
- Distributor
- MN, NE, TX
- Lot
- Lot: TS 2076
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Sweden
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