Devices

Device Recall Euro Diagnostica DIASTAT ANA (antinuclear antibody)

Model / Serial
Lot: TS 2076
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
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.
Manufacturer
Euro Diagnostica AB
1 Event
- Recall of Device Recall Euro Diagnostica DIASTAT ANA (antinuclear antibody)

Manufacturer

Euro Diagnostica AB

Manufacturer Address
Euro Diagnostica AB, Box 50117, Lundavagen 151, Malmo Sweden
Manufacturer Parent Company (2017)
C&P Investors Limited
Source
USFDA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)