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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Detail

Product Description HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion electrodes.
Recall Number Z-1141-2013
Classification Class II
Code Info Model Numbers: P400ISE110EN02 and P400ISE110US02. All Serial Numbers. Versions 5.0.7 and below
Product Distributed Qty 905 units
Reason For Recall HORIBA Medical is informing all ABX PENTRA 400 Analyzer with I.S.E. Module customers that there are no Linearity Limit Flags for the I.S.E. assays currently programmed into the ABX PENTRA 400 Analyzer software. All other assays run on this analyzer do have Linearity Limit Flags to alert the user to values that fall below or above the validated linearity range for each assay.

Event Detail

Event Id 64723
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 2013-03-20
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution.