Recall Z-0306-2018
Euro Diagnostica AB · initiated February 14, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot: TS 2076
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.
FDA-determined cause: Nonconforming Material/Component
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
Details
- Recall number
- Z-0306-2018
- Initiated
- February 14, 2017
- Posted by FDA
- December 20, 2017
- Terminated
- May 16, 2018
- Product code
- LKJ – Antinuclear Antibody, Antigen, Control
- Quantity
- 534 kits
- Distribution
- MN, NE, TX
- Recalling firm
- Euro Diagnostica AB, Malmo