Recall Z-0306-2018— Euro Diagnostica AB
Class II · Terminated
Class II FDA medical device recall by Euro Diagnostica AB, initiated 2017-02-14, terminated 2018-05-16. It names one FDA 510(k) clearance: K932876. 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.. 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..
- Recalling firm
- Euro Diagnostica AB
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-02-14
- Terminated
- 2018-05-16
- Firm location
- Malmo, N/A, Sweden
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.