Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HORIBA ABX PENTRA 400 I.S.E. Module Recalled by Horiba Instruments, Inc dba Horiba Medical Due to HORIBA Medical is informing all ABX PENTRA 400...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Horiba Instruments, Inc dba Horiba Medical directly.
Affected Products
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.
Quantity: 905 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Horiba Instruments, Inc dba Horiba Medical
Horiba Instruments, Inc dba Horiba Medical has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report