Euro Diagnostica AB: Medical Device Recall in 2018 - (Recall #: Z-0306-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 14, 2017

Date Posted: January 10, 2018

Recall Number: Z-0306-2018

Event ID: 77107

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.

Status: Terminated

Product Quantity: 534 kits

Code Information:

Lot: TS 2076

Distribution Pattern:

MN, NE, TX

Voluntary or Mandated:

Voluntary: Firm initiated