Home / Recalls / Horiba Instruments, Inc dba Horiba Medical / Z-1141-2013

Z-1141-2013 Class II Terminated

Recalled by Horiba Instruments, Inc dba Horiba Medical — Irvine, CA

Recall Details

Product Type
Devices
Report Date
April 24, 2013
Initiation Date
March 20, 2013
Termination Date
September 26, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
905 units

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.

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.

Distribution Pattern

Nationwide Distribution.

Code Information

Model Numbers: P400ISE110EN02 and P400ISE110US02. All Serial Numbers. Versions 5.0.7 and below

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