Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Mis-identification-If a panel or protocol is added to an existing worklist but the tube location is not specified, the CXP Acquisition software will run the last specified tube through the remaining protocols and will generate results and printouts of these runs leading to a Mis-Identification condition.

Recommended Action

Per FDA guidance

Customer letter -- A Product Corrective Action (PCA) letter was sent the week of July 24, 2006 to all accounts that have FC500 with CXP Software 2.0 and 2.1 to inform them that a potential sample misidentification may occur when running a Work list with missing tube Location(s) in Automatic MCL mode. The letter outlines actions to be taken to avoid mis-identification of patient results.