Euro Diagnostica DIASTAT ANA recall
Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive…
Why was Euro Diagnostica DIASTAT ANA 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: TS 2076
- Product
- Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive…
- Recalling firm
- Euro Diagnostica AB
- Quantity
- 534 kits
- Distribution
- MN, NE, TX
- Recall date
- January 10, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)