Reported Jan 16, 2013 · Terminated
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Horiba Instruments, Inc. dba Horiba Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Horiba Instruments, Inc dba Horiba Medical · 34 Bunsen · Irvine, CA · 92618-4210
Is this the product you have?
- ABX PENTRA ML
- Software Versions
V8.0.x and BelowV.9.0.1 and V9.0.2
- Lot codes and dates
- Lot/Serial# PML0937
- Amount recalled
- 10 units
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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