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U.S. Department of Health and Human Services

Class 3 Device Recall Unicel DxH 800 Coulter Cellular Analysis System

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  Class 3 Device Recall Unicel DxH 800 Coulter Cellular Analysis 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-1658-2010
Recall Event ID 55176
510(K)Number K081930  
Product Classification Counter, differential cell - Product Code GKZ
Product Unicel¿ DxH 800 Coulter¿ Cellular Analysis System. Beckman Coulter, Inc. Brea, CA.

Quantitative, automated hematology analyzer and for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Code Information Part number: 629029; All Serial Numbers.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information Contact
714-993-5321
Manufacturer Reason
for Recall		 Issue 1: The system will substitute or omit the characters # @ 1 \ ] ' ( I ) - when the instrument is configured in a language other than English, Chinese or Japanese. Example: Using the character @, a substitution in the string '123@456' would result in '123#456' and an omission would result in '123456'. Issue2: The characters 7 " and * (question mark, quotation mark, and asterisk) used as part
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 56 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.
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