Reported Mar 19, 2014 · Terminated
Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are…
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?
- Device NameABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s):
- N/A Software Version(s)All versions are subject to this correction
- Product UsageThe ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers
- Lot codes and dates
- Model/Part #(s): A11A01652 Lot/Serial #(s):
- N/A Software Version(s)All versions are subject to this correction
- Shelf LifeN/A
- Amount recalled
- 15
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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