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Terminated

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

FDA Recall Z-1438-2017 · Posted 2017-03-09

Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeGKZ
Date Initiated2017-02-13
Date Terminated2018-03-06
Product Quantity116

Reason for Recall

The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail and lead to instrument stoppage

Firm Action

Product correction letters were sent to all affected customers on February 13, 2017 by traceable method. Letters provided information on the reason for the correction with all affected serial numbers listed. Abbott will be contacting each location to schedule replacement of the PCBA Pump Relay Board. Update: five additional serial numbers were added. Correction letters were sent to new consignees - 3 in Brazil and 2 in Mexico.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US and Afghanistan, Brazil, Egypt, Tanzania, Hungary, Iraq, Kenya, Netherlands, Russia, Romania Vietnam, , United Kingdom, Saudi Arabia, Philippines, Lebanon, Mexico, Japan, Jordan, India, Indonesia, Turkey, UAE, Gaza & Jericho, Germany, Bulgaria, Chile, Argentina, Luxembourg.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061667CELL-DYN RUBY SYSTEMAbbott Laboratories · 2006-07-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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