Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ABX PENTRA ML Recalled by Horiba Instruments, Inc dba Horiba Medical Due to Horiba Medical is recalling ABX PENTRA ML because...
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
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Quantity: 10 units
Why Was This Recalled?
Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software
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