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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 04, 2010
Date Posted May 26, 2010
Recall Status1 Terminated 3 on September 02, 2014
Recall Number Z-1657-2010
Recall Event ID 55176
510(K)Number K032000  
Product Classification Counter, differential cell - Product Code GKZ
Product Coulter¿ LH 500 Series System. Beckman Coulter, Inc. Brea, CA.

Quantitative, automated hematology analyzer and leukocyte differential cell counter for in vitro diagnostic use in clinical laboratories.
Code Information Product LH500 100V Part number 178832; Product LH500 120V Part number 178833; Product LH500 240V Part Number 178834; All Serial Numbers.
Recalling Firm/
Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information Contact
Manufacturer Reason
for Recall
Issue 1: The system will substitute or omit the characters # @ [\] ' {I) when the system is configured in a language other than English or Chinese. Example: Using the character @, a substitution in the string '123@456' would result in '123#456' and an omission would result in '123456' Issue 2: The system will omit the character ~ regardless of language. Impact: There is a potential for Specimen
FDA Determined
Cause 2
Software design
Action Beckman Coulter, Inc. issued "Urgent: Product Corrective Action" notifications dated February 12, 2010. Consignees were informed of the affected product and instructed on proper actions. The firm also asked that the enclosed response forms be returned. For further information, contact your local Beckman Coulter Representative or call 1-800-526-7694.
Quantity in Commerce 1520 units
Distribution Distributed Nationwide 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.