Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA recallZ-0306-2018 · Euro Diagnostica AB · initiated Feb 14, 2017
Class II Terminated All recalls posted in December 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Euro Diagnostica AB or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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 [email protected]
Recall details
- Recall number
- Z-0306-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 14, 2017
- Posted by the FDA
- Dec 20, 2017
- Recalling firm
- Euro Diagnostica AB
- Quantity
- 534 kits
- Product code
- LKJ
- FDA submissions
- K932876
- Distribution
- MN, NE, TX
Product description
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.
Code information (models, lots, serial numbers)
Lot: TS 2076
Other devices under the same FDA submission
1 device cleared under K932876 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- DIASTAT ANA FANA200Svar Life Science AB · Antinuclear Antibody, Antigen, Control1 recall4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page