Horiba Instruments Inc: 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

Recalling firm

Horiba Instruments Inc

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.

Status

Terminated

Initiated

2014-11-19

Posted

2014-12-23

Terminated

2015-06-22

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 is

Root cause

Software change control

Action

ACTION/RESOLUTION: Before accepting any results please verify the Sample ID in the Worklist matches the Sample ID of the Patient information displayed for the results (Figure 1 below). If the two numbers do not match please contact HORIBA Medical Technical Support. Your Lite DM should be upgraded to V3.0.0.21. Please contact HORIBA Medical Technical Support to schedule an upgrade. Please call the following phone # 1(888) 903-5001 prompt # 3. Please share this information with your laboratory staff and retain this notification as part of your laboratory documentation. It is mandatory for you to complete and return the enclosed response form within 10 days, in order for us to verify your understanding of this Field Information Notice. If you have any questions or concerns, please contact your local HORIBA Medical representative. We sincerely apologize for any inconvenience this may cause your laboratory.

Quantity

322 (5 in U.S. Military)

Distribution

Nationwide within the U.S.

Lot, serial or model codes

Lot/Serial #(s): N/A Software Version(s): Versions 2.0.0.19 and lower. Expiration Date (s): N/A

510(k) numbers

not on file

PMA numbers

not on file

Product code

OUG

Firm FEI

3002698356

Firm city

Irvine

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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