FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0306-2018
- Recalling firm
- Euro Diagnostica AB
- 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.
- Status
- Terminated
- Initiated
- 2017-02-14
- Posted
- 2017-12-20
- Terminated
- 2018-05-16
- 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
- Lot, serial or model codes
- Lot: TS 2076
- 510(k) numbers
- ["K932876"]
- PMA numbers
- not on file
- Product code
- LKJ
- Firm FEI
- 3007610287
- Firm city
- Malmo
- Firm state
- not on file
- Firm country
- Sweden
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28