Recall Z-2337-2010 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
COULTER LH 500 Series System
| Date | Sep 1, 2010 (initiated Feb 12, 2010) |
| Status | Terminated |
| Reason | The recall was initiated after Beckman Coulter identified four (4) issues with the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System: Issue 1: There is a potential for misidentification to occur when the system is configured in languages other than English or Chinese. The characters #,@,[,\,],`,{,|,}, or ~ are substituted or omitted in other languages. The issu |
| Root cause | Software design |
| Action | The customer recall notification was initiated when Product Corrrective Actions letters with attached Customer Response form were sent on the week of February 15, 2010 to all customers who purchased the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System. The letters will provided the customers with an explanation of the problem identified and a work around. Customers with questions regarding the Product Corrective Action were instructed to call 800-526-7694 in the United States or Canada, or contact your local Beckman Coulter Representative. |
| Quantity | 1373 units in US and 147 units in Canada |
| Distribution | Throughout the United States and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032000 | COULTER LH 500 HEMATOLOGY ANALYZER Beckman Coulter, Inc., Aug 13, 2003 |