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U.S. Department of Health and Human Services

Enforcement Report - Week of January 16, 2013

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Event Detail

Event ID 63829
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 2012-09-20
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide in the US, including the states of CA, MI, IN, FL, and GA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2 Lot/Serial# PML0937 Class II Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software versions are Versions 9.0.1, 9.0.2, 8.0x and below. 10 units Z-0645-2013