Horiba Medical Recalls ABX Micros IM2 Data Management System
Horiba Medical is recalling 180 units of the ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may display incorrect patient test results, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Horiba Medical is recalling the ABX Micros IM2 Data Management System, which includes the IM2 Data Manager Software, a desktop computer, keyboard, mouse, and a unidirectional serial cable. The system is used to store, retrieve, and process laboratory data received from the ABX Micros 60.
The recall was initiated because the device may display incorrect patient test results under unanticipated operating conditions. This issue could lead to the processing of inaccurate laboratory data.
Approximately 180 units were distributed nationwide. The recall covers all serial numbers for the affected part numbers M60CSB110EN04 and D00A00202. Users should contact Horiba Medical for further instructions on how to proceed with the recall.
The recalled product
- 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 v
- Manufacturer
- Horiba Instruments, Inc dba Horiba Medical
- Hazard
- Affected units
- 180
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Distributed nationwide across the United States.
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