ClearanceBrief
Recall Z-0040-04 ยท GKZ Counter, Differential Cell

Beckman Coulter Inc

Coulter AcT 5diff Cap Pierce Hematology Analyzers Part Numbers: 6605641, 6605705

DateOct 15, 2003 (initiated Sep 8, 2003)
StatusTerminated
ReasonSamples with high fat content will not count platelets accurately.
Root causeOther
ActionFirm issued an advisory letter to users to retain as part of the Quality Manual for the instruments. It cautions to check specimens for interfering lipemia. Letter was sent 9/8/2003.
Quantity451
DistributionUnited States and Canada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.