Recall Z-0306-2018 ยท LKJ Antinuclear Antibody, Antigen, Control
Euro Diagnostica AB
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.
| Date | Dec 20, 2017 (initiated Feb 14, 2017) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 534 kits |
| Distribution | MN, NE, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932876 | DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT Shield Diagnostics, Ltd., Nov 15, 1993 |