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

Recall Z-1438-2017 — CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories

U.S. FDA — Device Enforcement · United States · 2017-02-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1438-2017
Date of alert
2017-02-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Abbott Laboratories
Product category
device
Product type
Devices
Reported risk: The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail and lead to instrument stoppage
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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