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U.S. Department of Health and Human Services

Class 2 Device Recall CELLDYN Ruby System

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  Class 2 Device Recall CELLDYN Ruby System see related information
Date Initiated by Firm February 13, 2017
Date Posted March 09, 2017
Recall Status1 Terminated 3 on March 06, 2018
Recall Number Z-1438-2017
Recall Event ID 76481
510(K)Number K061667  
Product Classification Counter, differential cell - Product Code GKZ
Product 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
Code Information Affected serial numbers:  70002BG 70026BG 70050BG 70076BG 70105BG 70141BG 70003BG 70028BG 70051BG 70077BG 70106BG 70142BG 70004BG 70029BG 70052BG 70079BG 70107BG 70144BG 70005BG 70030BG 70054BG 70082BG 70113BG 70146BG 70006BG 70031BG 70056BG 70084BG 70114BG 70147BG 70007BG 70032BG 70058BG 70086BG 70119BG 70149BG 70008BG 70033BG 70059BG 70087BG 70120BG 70164BG 70009BG 70034BG 70061BG 70088BG 70124BG 70165BG 70010BG 70035BG 70063BG 70089BG 70125BG 70166BG 70011BG 70036BG 70064BG 70090BG 70127BG 70167BG 70012BG 70037BG 70065BG 70091BG 70129BG 70170BG 70013BG 70038BG 70067BG 70092BG 70130BG 70171BG 70014BG 70039BG 70068BG 70093BG 70131BG 70178BG 70016BG 70040BG 70069BG 70094BG 70132BG 70181BG 70018BG 70042BG 70070BG 70095BG 70133BG 70183BG 70019BG 70043BG 70071BG 70096BG 70134BG 70189BG 70020BG 70044BG 70072BG 70099BG 70136BG 70021BG 70045BG 70073BG 70100BG 70137BG 70024BG 70046BG 70074BG 70103BG 70138BG 70025BG 70047BG 70075BG 70104BG 70140BG.  UPDATE: 2-28-17 - five additional serial numbers added: 55899BG,  55900BG,  55901BG,  55902BG  55904BG.
Recalling Firm/
Manufacturer		 Abbott Laboratories
4551 Great America Pkwy
Santa Clara CA 95054-1208
For Additional Information Contact Albert A. Chianello
224-668-1923
Manufacturer 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
FDA Determined
Cause 2		 Nonconforming Material/Component
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.
Quantity in Commerce 116
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GKZ and Original Applicant = ABBOTT LABORATORIES
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