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.
FDA Recall Z-1141-2013 · Posted 2013-04-18
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Recalling FirmHoriba Instruments, Inc dba Horiba Medical
Recall StatusTerminated
Product CodeJGS
Date Initiated2013-03-20
Date Terminated2014-09-26
Product Quantity905 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.
Firm Action
A recall letter, Field Safety Notice & Acknowledgement mailed to the customers March 20, 2013. The letter included the product information, reason for recall, instructions on what to do with the recalled product, and contact information:"If you have any questions or concerns, please contact your local HORIBA Medical
representative. We sincerely apologize for any inconvenience this may cause your laboratory. Please contact your Customer Service Representative at 1-888-903-5001 (option 3) for any additional questions related to this customer
letter."
Root Cause
Software design
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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