ClearanceBrief
Recall Z-0417-03 ยท GKZ Counter, Differential Cell

Beckman Coulter Inc

COULTER LH 700 Series Hematology Analyzers

DateJan 9, 2003 (initiated Nov 8, 2002)
StatusTerminated
ReasonSoftware.
Root causeOther
ActionCustomers received a telephone call and a faxed Product Corrective Action letter dated Nov. 8, 2002 which includes modified operating instructions. Additionally an updated software version was released and installed on all affected customers units. This recall is complete.
Quantity132
DistributionNationwide and Canada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.