ClearanceBrief
Recall Z-1342-04 ยท GJH Stain, Reticulocyte

ABX Diagnostics Inc

PENTRA 120 and PENTRA 120 Retic Hematology Analyzer

DateAug 13, 2004 (initiated Jun 24, 2004)
StatusTerminated
ReasonPower failure having impact on software.
Root causeOther
ActionFirm sent a notification / recall letter and response card dated June 24,2004 and promised to provide software shortly.
Quantity81
DistributionNationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K022200PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120
Abx Diagnostics, Jul 29, 2002