Coulter HmX Hematology Analyzer, Part number: 6605522, 6605523, 6605524. 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.
Recall
- Recall Number
- Z-0600-2012
- Event Number
- 60367
- Firm
- Beckman Coulter Inc.
- FEI Number
- 2050012
- Product Code
- GKZ
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- October 13, 2011
- Posted
- January 11, 2012
- Terminated
- June 1, 2012
- Address
- 250 S Kraemer Blvd, Brea, CA, 92821-6232
Description
Coulter HmX Hematology Analyzer, Part number: 6605522, 6605523, 6605524. 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.
The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer.
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.
Worldwide Distribution.
6 units total