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U.S. Department of Health and Human Services

Class 2 Device Recall COULTER MAXM Hematology Analyzer

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  Class 2 Device Recall COULTER MAXM Hematology Analyzer see related information
Date Initiated by Firm October 13, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on June 01, 2012
Recall Number Z-0602-2012
Recall Event ID 60367
510(K)Number K922704  
Product Classification Counter, differential cell - Product Code GKZ
Product COULTER MAXM Hematology Analyzer/MAXM Hematology Analyzer with Autoloader
Part number: 6705995, 6705996, 6705997/
Part number: 6705998, 67059999, 6706000.

HmX Hematology Analyzer / HmX Hematology Analyzer with Autoloader PN 4237523 Rev C. The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories.
Code Information N/A
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Clair K. O'Donovan, Ph.D.
714-961-4483
Manufacturer Reason
for Recall
The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated October 13, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were instructed to contact Beckman Coulter Service at (800) 526-7694 if they were experiencing failures. Customers not experiencing failures, but their system may have the suspect chips, were told they would be contacted by Beckman Coulter Service to correct their problem. Customers were also instructed to complete and return an enclosed Response Form.
Quantity in Commerce 1 unit total
Distribution Worldwide Distribution.
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 = COULTER ELECTRONICS, INC.
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