Horiba Medical Recalls ABX PENTRA ML Software Due to Data Transmission Bug
Horiba Medical is recalling ABX PENTRA ML software because a bug may transmit incorrect results to Laboratory Information Systems.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device software) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Horiba Medical is recalling all software versions of the ABX PENTRA ML (Model A11A06152). The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.
The recall was initiated due to a software bug that has the potential to transmit incorrect results to the Laboratory Information System. This issue affects all software versions of the device.
The recall covers 15 units distributed nationwide in the USA. Users of this software should contact Horiba Medical for further instructions regarding the correction of this software defect.
The recalled product
- Product
- 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.
- Manufacturer
- Horiba Instruments, Inc dba Horiba Medical
- Category
- Medical Device — Software
- Affected units
- 15
Distribution
Distributed nationwide across the United States.
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