Z-0306-2018 Class II Terminated
FDA device recall Z-0306-2018 was initiated by Euro Diagnostica AB on February 14, 2017 and is designated Class II. 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. The recall status is terminated (terminated May 16, 2018). Affected quantity: 534 kits.
Recall Details
- Product Type
- Devices
- Report Date
- January 10, 2018
- Initiation Date
- February 14, 2017
- Termination Date
- May 16, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 534 kits
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.
Distribution Pattern
MN, NE, TX
Code Information
Lot: TS 2076