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

Recall Z-2363-2019 — Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a clinical chemistry mo

U.S. FDA — Device Enforcement · Germany · 2019-06-10 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2363-2019
Date of alert: 2019-06-10
Country / jurisdiction: Germany
Risk level: Class II
Risk type: recall
Brand: Abbott Gmbh & Co. KG
Product category: device
Product type: Devices

Reported risk: Abbott has identified an issue with all on market versions (v2.6.0 and v2.6.1) of Alinity ci series Software where incorrect results may occur after a system Stop due to the Alinity i re use of reaction vessels (RVs). This issue only occurs if the system is transitioned from Processing to Stopped to Idle.

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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