[Recalled] 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

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Horiba Instruments, Inc dba Horiba Medical

• ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received via a unidirectional — Class III
• Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High). Minotrol 16 is a tri-level control intended for in vitro diagnostic use in monitoring the accuracy and precision on HORIBA Medical hematology blood cell counters using HORIBA Medical reagents. — Class III
• ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes. — Class II
• ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic met — Class III
• ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex. — Class II
• 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400 — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.