CompanyHoriba Instruments, Inc dba Horiba Medical.
Date of Enforcement Report:3/19/2014
Class lI:
PRODUCT
Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.Recall Number Z-1173-2014
REASON
HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a software bug with the potential of transmitting incorrect results to the Laboratory Information System..
RECALLING FIRM/MANUFACTURER
Horiba Instruments, Inc dba Horiba Medical, Irvine, CA on.2/14/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
15
DISTRIBUTION
Nationwide
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