Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): Recalled by Horiba Instruments, Inc dba Horiba Medical Due to HORIBA Medical initiated this recall of all software...
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
Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.
Quantity: 15
Why Was This Recalled?
HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a software bug with the potential of transmitting incorrect results to the Laboratory Information System.
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