Recall Z-0113-2014 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
COULTER LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RB
| Date | Nov 1, 2013 (initiated Sep 24, 2013) |
| Status | Terminated |
| Reason | The check valves may fail on the Coulter LH 750 Hematology Analyzer (PN 6605632 and A85570) and Coulter LH 780 Hematology Analyzer (PN 723585 and A90728). A failure may result in an air or liquid leak at the connection to the Vacuum Overflow Tank waste line or at the Backwash Tank drain line. |
| Root cause | Component change control |
| Action | Beckman Coulter sent a Urgent Product Correction letter dated September 12, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. . The customer notification letter dated September 12, 2013, titled "URGENT PRODUCT CORRECTION", provided product description with codes, the issue (reason for recall), impact, action, resolution, and contact information. Customers were instructed to: If you experience a "Backwash Tank Not Full" error message, review manual mode sample results since the last acceptable QC run. System safe |
| Quantity | 1,697 units |
| Distribution | Worldwide Distribution - Nationwide Distribution and the country of Canada.. |
| FDA record | Open on fda.gov |