Z-0856-2015Class II

Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model #: D00A00224D The...

Name: Z-0856-2015 Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model #: D00A00224D The...
Creator: Horiba Instruments Inc
Published: 2014-11-19
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2014-11-19 / Terminated / root cause: software

FDA source

Horiba Instruments Inc began a recall of 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... on 2014-11-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0856-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-19
Posted: 2014-12-23
Terminated: 2015-06-22
Recalling firm: Horiba Instruments Incorporated
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.
Product code: OUG Medical Device Data System
Reason for recall: 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 tag: software
FDA 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 in commerce: 322 (5 in U.S. Military)
Distribution: Nationwide within the U.S.
Product codes and lots: Lot/Serial #(s): N/A Software Version(s): Versions 2.0.0.19 and lower. Expiration Date (s): N/A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0856-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0856-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-23

Product code OUG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)