FDA-Device2013-04-10Class III
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.
Horiba Instruments, Inc dba Horiba Medical
Hazard
Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.
Sold states
Nationwide Distribution
Affected count
180 units
Manufactured in
34 Bunsen, N/A, Irvine, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1050-2013Don't want to check this manually?
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