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

Recall Z-2919-2018 — is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sj¿gre

U.S. FDA — Device Enforcement · Sweden · 2016-10-21 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2919-2018
Date of alert: 2016-10-21
Country / jurisdiction: Sweden
Risk level: Class III
Risk type: recall
Brand: Euro Diagnostica AB
Product category: device
Product type: Devices

Reported risk: Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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