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.
This recall has been terminated (originally issued December 20, 2017).
- Company
- Euro Diagnostica Ab
- Recall Initiated
- February 14, 2017
- Posted
- December 20, 2017
- Terminated
- May 16, 2018
- Recall Number
- Z-0306-2018
- Quantity
- 534 kits
- Firm Location
- Malmo Sweden
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
MN, NE, TX
Lot / Code Info
Lot: TS 2076
Root Cause
Nonconforming Material/Component
Action Taken
Consignees were notified by phone or email beginning 2/15/2017. The Urgent Field Safety Notice identified affected product, described the issue, and stated affected product should be destroyed. A response form was asked to be returned. Questions can be directed to Malin Bornschein at malin.bornschein@eurodiagnostica.com
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