Z-1141-2013Class II

HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers...

Name: Z-1141-2013 HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers...
Creator: Horiba Instruments, Inc dba Horiba Medical
Published: 2013-03-20
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2013-03-20 / Terminated / root cause: software

FDA source

Horiba Instruments, Inc dba Horiba Medical began a recall of 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... on 2013-03-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1141-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-20
Posted: 2013-04-18
Terminated: 2014-09-26
Recalling firm: Horiba Instruments Incorporated
Product: 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.
Product code: JGS Electrode, Ion Specific, Sodium
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.
Root cause tag: software
FDA root cause: Software design
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."
Quantity in commerce: 905 units
Distribution: Nationwide Distribution.
Product codes and lots: Model Numbers: P400ISE110EN02 and P400ISE110US02. All Serial Numbers. Versions 5.0.7 and below

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1141-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1141-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-18

Product code JGS

K052007Class IIAbx Pentra 400 Clinical Chemistry Analyzer (Option: I.s.e. Module)Horiba Abx / cleared 2005-12-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)