31
Dec
2014

Cl II Horiba Lite DM Software

0

Company:Horiba Instruments Inc.
Date of Enforcement Report 12/31/2014
Class lI:

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) results from an ABX Micros 60 Hematology Analyzer or ABX Micros CRP 200 Hematology Analyzer. Only one instrument connection is allowed per each Lite DM workstation. The Lite DM application runs on a PC within a Windows Operating System platform. Data transmitted from the instrument to the Lite DM workstation is a Serial RS-232 unidirectional ABX Format communication. The Lite DM can act as a standalone data manager for data received from the instrument, or allow transmission of this data to a Host (LIS  Laboratory Information System or EMR  Electronic Medical Record system). Following the completion of each blood sample analysis performed on the connected HORIBA Medical hematology analyzer, results are then communicated (uni-directional) to the Lite DM workstation. Results received will display to the user in a specific color coding format indicating any normal or panic reference range violations. Results are then rejected or accepted by the user for final reporting – formatted to guidelines stipulated by CLIA. At no time are any results interpreted; only reported for review and appropriate action.
Recall Number Z-0856-2015

REASON
HORIBA Medical is informing all HORIBA Medical Lite DM customers using software version 2.0.0.19 and lower of a software bug related to the potential for results received being applied to the wrong order in the Lite DM Worklist. This bug has not been seen in software versions above V2.0.0.19 IMPACT: Potential for results received being applied to the wrong order in the Lite DM Worklist. The issue can occur from a specific sequence of steps 1. The Lite DM Worklist must be enabled (and) 2. Multiple orders must be created in the Lite DM Worklist (and) 3. The order panel is changed or selected after the order is created and left in edit mode a. panel edit mode = drop down arrow for the panel selection is still visible

RECALLING FIRM/MANUFACTURER
Horiba Instruments Inc, Irvine, CA, on 11/19/2014. Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
322

DISTRIBUTION
Nationwide

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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