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U.S. Department of Health and Human Services

Class 3 Device Recall COULTER LH 500 Series System

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  Class 3 Device Recall COULTER LH 500 Series System see related information
Date Initiated by Firm February 12, 2010
Date Posted September 01, 2010
Recall Status1 Terminated 3 on September 10, 2010
Recall Number Z-2337-2010
Recall Event ID 55699
510(K)Number K032000  
Product Classification Counter, Differential Cell - Product Code GKZ
Product COULTER LH 500 Series System
Code Information All serial Numbers.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information Contact Clair K. O'Donovan, Ph.D.
714-961-4483
Manufacturer Reason
for Recall		 The recall was initiated after Beckman Coulter identified four (4) issues with the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System: Issue 1: There is a potential for misidentification to occur when the system is configured in languages other than English or Chinese. The characters #,@,[,\,],`,{,|,}, or ~ are substituted or omitted in other languages. The issu
FDA Determined
Cause 2		 Software design
Action The customer recall notification was initiated when Product Corrrective Actions letters with attached Customer Response form were sent on the week of February 15, 2010 to all customers who purchased the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System. The letters will provided the customers with an explanation of the problem identified and a work around. Customers with questions regarding the Product Corrective Action were instructed to call 800-526-7694 in the United States or Canada, or contact your local Beckman Coulter Representative.
Quantity in Commerce 1373 units in US and 147 units in Canada
Distribution Throughout the United States and Canada
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 = BECKMAN COULTER, INC.
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