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Horiba Instruments, Inc dba Horiba Medical recalls Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subj
Recalled March 19, 2014 · FDA recall Z-1173-2014 · Horiba Instruments, Inc
Hazard
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. · FDA Class II
Units
15
Sold at
USA Nationwide Distribution
Description
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.
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.
Manufacturer(s)
Horiba Instruments, Inc dba Horiba Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →