Recalls / —
—#105175
Product
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.
- FDA product code
- GKZ — Counter, Differential Cell
- Device class
- Class 2
- Medical specialty
- Hematology
- 510(k) numbers
- K010765
- Affected lot / code info
- N/A
Why it was recalled
The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Beckman Coulter Inc.
- Address
- 250 S Kraemer Blvd, Brea, California 92821-6232
Distribution
- Distribution pattern
- Worldwide Distribution.
Timeline
- Recall initiated
- 2011-10-13
- Posted by FDA
- 2012-01-11
- Terminated
- 2012-06-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #105175. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.