ClearanceBrief
Recall Z-0266-05 ยท GKZ Counter, Differential Cell

Beckman Coulter Inc

CXP software for Cytomics FC500 Cytometer

DateNov 30, 2004 (initiated Nov 2, 2004)
StatusTerminated
ReasonIncorrect sample identification can be displayed and printed on the Runtime Panel Report due to a software defect.
Root causeOther
ActionThe Product Corrective Action Customer Letter which includes Modified Operating Instructions was sent to US and Canadian customers the week of November 8, 2004 via US Mail.
Quantity167
DistributionNationwide and Canada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.