ClearanceBrief
Recall Z-0002-05 ยท GKZ Counter, Differential Cell

ABX Diagnostics Inc

Automated Differential Cell Counter

DateOct 5, 2004 (initiated Aug 13, 2004)
StatusTerminated
ReasonDevice can generate overestimated platelet results.
Root causeOther
ActionSoftware problem, device may give overestimated platelet results.
Quantity91
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K024002PENTRA 80
Abx Diagnostics, Jan 3, 2003