ClearanceBrief
Recall Z-0571-03 ยท

Beckman Coulter Inc

Coulter LH 700 Series and GEN S Hematology Analyzers 864.5220 Automated differential cell counter

DateFeb 25, 2003 (initiated Dec 10, 2002)
StatusTerminated
ReasonDevice design allows for cross contamination issue to occur, possibly affecting assays and results reports.
Root causeOther
ActionFirm will check and shorten sweepflow tubing on a next visit basis during routine service visits.
Quantity447
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
K962988COULTER GEN-S SYSTEM
Coulter Corp., Oct 30, 1996