Recall Z-1173-2014— Horiba Instruments, Inc dba Horiba Medical

Name: FDA recall Z-1173-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-14

Class II · Terminated

Class II FDA medical device recall by Horiba Instruments, Inc dba Horiba Medical, initiated 2014-02-14, terminated 2014-08-22. It names one FDA 510(k) clearance: K053308. 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.. 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: Horiba Instruments, Inc dba Horiba Medical
Classification: Class II
Status: Terminated
Initiated: 2014-02-14
Terminated: 2014-08-22
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K053308 — ABX MICROS CRP 200, OPTION IMHoriba Abx·cleared 2005-12-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.