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
- Recall Number
- Z-0306-2018
- Event Number
- 77107
- Firm
- Euro Diagnostica AB
- FEI Number
- 3007610287
- Product Code
- LKJ
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- February 14, 2017
- Posted
- December 20, 2017
- Terminated
- May 16, 2018
- Address
- Box 50117, Lundavagen 151, Malmo Sweden
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.
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.
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]
MN, NE, TX
534 kits