Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test resul
FDA device recall Z-0306-2018 · posted 2017-12-20 · Terminated
Recall details
- Recalling firm
- Euro Diagnostica AB
- 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.
- 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
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LKJ
- Quantity affected
- 534 kits
- Distribution
- MN, NE, TX
- Date initiated
- 2017-02-14
- Date posted
- 2017-12-20
- Date terminated
- 2018-05-16
- Location
- Malmo, Sweden
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT (K932876) | Shield Diagnostics, Ltd. | 1993-11-15 |