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

Recall Z-0330-2014 — The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specia

U.S. FDA — Device Enforcement · United States · 2013-03-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0330-2014
Date of alert: 2013-03-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GE Healthcare It
Product category: device
Product type: Devices

Reported risk: GE Healthcare has become aware of a potential safety issue associated with the use of GE Centricity Laboratory where panel reflex does not occur if DIP.Specimen is blank. Panel reflexing fails to occur when ad-hoc re-routing functionality is used and the following are true: 1) The ordered panel is a slave panel, and; 2) The panitem specimen group field of one or more of the ordered items on the ma

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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