Recall Z-0645-2013— Horiba Instruments, Inc dba Horiba Medical
Class II · Terminated
Class II FDA medical device recall by Horiba Instruments, Inc dba Horiba Medical, initiated 2012-09-20, terminated 2013-03-12. FDA's recall record names no specific 510(k) clearance for this event. Product: ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2. Reason: Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software.
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-20
- Terminated
- 2013-03-12
- Firm location
- Irvine, CA, United States
Product description
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Reason for recall
Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software
Data sourced from openFDA. This site is unofficial and independent of the FDA.