ClearanceBrief
Recall Z-0259-05 ยท GKZ Counter, Differential Cell

Beckman Coulter Inc

CXP Software Version 1.0 and 1.1 (operating software for Cytomics FD500 Cytometer. Part numbers: 624281, 623560, 623563, 623554, 623555, 623541, 623556, 623557, 623558, 623559.

DateNov 30, 2004 (initiated Aug 2, 2004)
StatusTerminated
ReasonSoftware anomaly.
Root causeOther
ActionA recall letter and workaround solution were mailed August 2, 2004. Firm will initiate a software upgrade as well.
Quantity89
DistributionNationwide and Canada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.