Coulter HmX Hematology Analyzer with Autoloader, Part number: 6605525, 6605526, 6605527. HmX Hematology Analyzer / HmX H
FDA device recall Z-0601-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 98 units total
- Distribution
- Worldwide Distribution.
- Date initiated
- 2011-10-13
- Date posted
- 2012-01-11
- Date terminated
- 2012-06-01
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526 (K010765) | Beckman Coulter, Inc. | 2001-04-13 |