Recall Z-0471-2014 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
Coulter LH 780 Hematology Analyzer, Part No. 723585, A90728 Product Usage: Coulter LH 780 Hematology Analyzer is a is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter LH 780 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well
| Date | Dec 10, 2013 (initiated Nov 8, 2013) |
| Status | Terminated |
| Reason | Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), white blood cell differential and/or reticulocytes. |
| Root cause | Under Investigation by firm |
| Action | Beckman Coulter sent an customer notification letter dated 11/8/13 to all customers who purchased the LH 750 and LH 780 Hematology Systems. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to contact Beckman Coulter's Customer Support Center at http://www.beckmancoulter.com/customer/support or call (800) 526-7694 in the US and Canada. Outside the US and Canada, customers are instructed to contact Beckman Coulter Represent |
| Quantity | 1961 units total (610 units in US) |
| Distribution | Worldwide Distribtion - USA Nationwide including the countries of Algeria, Andorra, Angola, Australia, Austria, Bahrain, Bangladesh, Belgium, Bermuda, Bosnia and Herzegovina, Bulgaria, China, Colombia, Croatia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, Hong Kong, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061616 | COULTER LH 780 HEMATOLOGY ANALYZER Beckman Coulter, Inc., Oct 4, 2006 |