Home / Recalls / Medical Devices
Horiba Instruments, Inc dba Horiba Medical recalls ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Sof
Recalled April 10, 2013 · FDA recall Z-1050-2013 · Horiba Instruments, Inc
Hazard
Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions. · FDA Class III
Units
180 units
Sold at
Nationwide Distribution
Description
Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.
Product
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 serial connection from the ABX Micros 60.
Manufacturer(s)
Horiba Instruments, Inc dba Horiba Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →