HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers:… recallZ-1141-2013 · Horiba Instruments, Inc dba Horiba Medical · initiated Mar 20, 2013
Class II Terminated All recalls posted in April 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Horiba Instruments, Inc dba Horiba Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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."
Recall details
- Recall number
- Z-1141-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 20, 2013
- Posted by the FDA
- Apr 18, 2013
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- Quantity
- 905 units
- Product code
- JGS
- FDA submissions
- K052007
- Distribution
- Nationwide Distribution.
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.
Code information (models, lots, serial numbers)
Model Numbers: P400ISE110EN02 and P400ISE110US02. All Serial Numbers. Versions 5.0.7 and below
Other devices under the same FDA submission
1 device cleared under K052007 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ABX PENTRA ETCHING CP 1220001769Horiba Abx Sas · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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