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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
ABX Pentra ML		see related information
Date Posted January 07, 2013
Recall Number Z-0645-2013
Product ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Code Information Lot/Serial# PML0937
Recalling Firm/
Manufacturer		 Horiba Instruments, Inc dba Horiba Medical
34 Bunsen
Irvine, California 92618-4210
Reason for
Recall		 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
Action An "Urgent: Field Safety Notice" letter dated 11/09/2012 was sent to all customers who received the ABX PENTRA ML products. The letter informed the customers of the problem identified and the action to be taken. Customers were instructed to complete and return the enclose response form within 10 days. Customers with questions about the letter are instructed to contact their local HORIBA Medical representative.
Quantity in Commerce 10 units
Distribution Nationwide in the US, including the states of CA, MI, IN, FL, and GA.
 
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