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U.S. Department of Health and Human Services

Class 2 Device Recall Bayer Advia 70 Hematology Analyzer

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  Class 2 Device Recall Bayer Advia 70 Hematology Analyzer see related information
Date Initiated by Firm August 24, 2006
Date Posted January 09, 2007
Recall Status1 Terminated 3 on March 10, 2008
Recall Number Z-0449-2007
Recall Event ID 36706
510(K)Number K991539  
Product Classification Hematology Analyzer - Product Code GKZ
Product Drew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.
Code Information All lots.
Recalling Firm/
Manufacturer
Drew Scientific Group PLC
4230 Shilling Way
Dallas TX 75237-1023
Manufacturer Reason
for Recall
Flags and alerts on the user interface will not automatically transfering to the LIS.
FDA Determined
Cause 2
Other
Action Firm sent 'Product Notification #22' to all customers on 08/24/06. Users advised of potential risk to patient health and provided with instructions on how to eliminate risk by disabling the auto transfer feature and manually transfering data until a software patch is made available
Quantity in Commerce 299 units.
Distribution Worldwide distribution --- including USA states of FL, MA, MN, ND, NM, NY, Puerto Rico and TX and countries of Austria, Bangladesh, Chile, China, Czech Republic, Egypt, France, Hong Kong, Italy, India, Iran, Korea, Mexico, Morocco, Phillipines, Portugal, Russia, Serbia and Montenegro, Spain, Syria, Thailand, Turkey, United Arab Emerates (Dubai), United Kingdom and Vietnam, West Indies and Yemen.-
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 = MWI, INC.
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