Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0306-2018 — 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.

U.S. FDA — Device Enforcement · Sweden · 2017-02-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0306-2018
Date of alert: 2017-02-14
Country / jurisdiction: Sweden
Risk level: Class II
Risk type: recall
Brand: Euro Diagnostica AB
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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