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

Recall Z-1197-2019 — Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c

U.S. FDA — Device Enforcement · Germany · 2019-02-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1197-2019
Date of alert: 2019-02-26
Country / jurisdiction: Germany
Risk level: Class II
Risk type: recall
Brand: Abbott Gmbh & Co. KG
Product category: device
Product type: Devices

Reported risk: The safety interlock covering the septum piercing probes within the bulk solution bottle holder may not deploy when a bulk solution bottle is removed from the Alinity ci series and Alinity s System.

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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