CLASS III Device recall · Reported 10 Apr 2013 · FDA Enforcement Report
ABX Micros IM2, Part# M60CSB110EN04 recalled by Horiba Instruments
Horiba Instruments is recalling ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists, distributed nationwide in the US. The recall was initiated on 15 Feb 2013 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1050-2013
- FDA event ID
- 64386
- Recalling firm
- Horiba Instruments, Irvine, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Feb 2013
- FDA classified
- 3 Apr 2013
- Reported
- 10 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 15 Feb 2013 | Recall initiated by company | |
| 3 Apr 2013 | Classified by FDA | +47 days |
| 10 Apr 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.
Which lots are affected?
All serial numbers
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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