Horiba Lite DM Software Recall for Potential Data Mismatch
Horiba Instruments is recalling Lite DM software versions 2.0.0.19 and lower due to a bug that may apply test results to the wrong patient order.
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 criteria for a High severity score.
Plain-English summary
Horiba Instruments Inc is recalling the Lite DM (Lite Data Manager) software, specifically versions 2.0.0.19 and lower, used with ABX Micros 60 and ABX Micros CRP 200 Hematology Analyzers. The recall is due to a software bug that creates the potential for received test results to be applied to the wrong order in the Lite DM Worklist.
The affected software is distributed nationwide within the U.S., with 322 units identified, including 5 in the U.S. Military. The bug has not been observed in software versions above V2.0.0.19. The Lite DM application is designed to receive, store, and manage startup, patient, and quality control results from the connected hematology analyzers.
Customers using the affected software versions should contact Horiba Medical for information on corrective actions. The recall addresses the risk of data integrity issues where patient results might be incorrectly associated with a different patient's order.
The recalled product
- Product
- Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model #: D00A00224D The Lite DM (Lite Data Manager) is a software application developed by HORIBA Medical intended to receive, store, and manage Startup, Patient, and Quality Control (QC)…
- Manufacturer
- Horiba Instruments Inc
- Category
- Medical Device — Software
Distribution
Distributed nationwide across the United States.
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