Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 31, 2014
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
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 ap…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Horiba Instruments Inc recalled Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Mo… - a moderate-severity action.
Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Mo… was recalled by Horiba Instruments Inc in December 31, 2014. Reason: HORIBA Medical is informing all HORIBA Medical Lite DM customers using software version 2.0.0.19 and lower of…. Check the official notice for the remedy. Verify recall #Z-0856-2015 with the FDA Devices before acting.
The recall
Horiba Instruments Inc issued this moderate-severity FDA Devices recall-HORIBA Medical is informing all HORIBA Medical Lite DM customers using software version 2.0.0.19 and lower of….
- Moderate
- severity level
- Class II
- classification
- December 31, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0856-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0856-2015) was formally reported on December 31, 2014, with the manufacturer initiating the action on November 19, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Horiba Instruments Inc is listed as the recalling firm, operating out of Irvine, CA. Federal records list the affected scope as 322 (5 in U.S. Military).
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Nationwide within the U.S.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
322 (5 in U.S. Military)
Related Recalls
6
3 from same agency
Product description
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.
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0856-2015 |
| Date reported | December 31, 2014 |
| Date initiated | November 19, 2014 |
| Recalling firm | Horiba Instruments Inc |
| Firm location | Irvine, CA |
| Affected scope | 322 (5 in U.S. Military) |
| Distribution | Nationwide within the U.S. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0856-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Horiba Instruments Inc. Units affected: 322 (5 in U.S. Military).
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 31, 2014. Severity: Moderate. Recall number: Z-0856-2015.
Where was the recalled product distributed? ▼
Distribution: Nationwide within the U.S..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0856-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 31, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.