FDAFDA · Food and drugs·Recall number Z-1173-2014
Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.
Published March 19, 2014 · Recall initiated: February 14, 2014
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 initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a software bug with the potential of transmitting incorrect results to the Laboratory Information System.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Horiba Instruments, Inc dba Horiba Medical
- Distributor
- USA Nationwide Distribution
- Lot
- Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Shelf Life: N/A
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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