ClearanceBrief
Recall Z-0669-03 ยท GKZ Counter, Differential Cell

Beckman Coulter Inc

LH 700 Series Hematology Analyzers. Part numbers 66056032, 6605633, 6605645

DateMar 21, 2003 (initiated Dec 27, 2002)
StatusTerminated
ReasonIncorrect Hemoglobin result can be reported with software version 2A and higher.
Root causeOther
ActionCustomers were contacted by telephone and mail from 1/27/03 to 2/3/2003. Notice included modified operating instructions. A software fix is being developed and will be installed by Beckman personnel.
Quantity234
DistributionNationwide and Canada.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K011342COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
Beckman Coulter, Inc., Jul 9, 2001