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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

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.
Recall Number Z-1173-2014
Classification Class II
Code Info Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Shelf Life: N/A
Product Distributed Qty 15
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.

Event Detail

Event Id 67528
Product Type Devices
Status Ongoing
Recalling Firm Horiba Instruments, Inc dba Horiba Medical
City Irvine
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-14
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA Nationwide Distribution
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