FDA recall Z-0306-2018

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 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

MN, NE, TX

Key facts

Status

Terminated

Initiation date

2017-02-14

Report date

2018-01-10

Termination date

2018-05-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Malmo, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0306-2018