FDAFDA · Food and drugs·Recall number Z-0645-2013
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Published January 16, 2013 · Recall initiated: September 20, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Horiba Instruments, Inc dba Horiba Medical
- Distributor
- Nationwide in the US, including the states of CA, MI, IN, FL, and GA. Center Recall Depth is Retail.
- Lot
- Lot/Serial# PML0937
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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