FDA Device recall Z-0306-2018
Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumpt…
- FDA Device
- Class II
- terminated
- Published 2018-01-10
On 2018-01-10 the FDA classified a Class II recall of Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumpt… by Euro Diagnostica Ab, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0306-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-14 |
| Published | 2018-01-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Euro Diagnostica Ab |
| Distribution | MN, NE, TX |
Product
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.
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.
Identifiers
| code_info | Lot: TS 2076 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0306-2018%22
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