Recall Z-1050-2013— Horiba Instruments, Inc dba Horiba Medical
Class III · Terminated
Class III FDA medical device recall by Horiba Instruments, Inc dba Horiba Medical, initiated 2013-02-15, terminated 2014-08-11. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions..
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-02-15
- Terminated
- 2014-08-11
- Firm location
- Irvine, CA, United States
Product description
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.
Reason for recall
Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.
Data sourced from openFDA. This site is unofficial and independent of the FDA.