| Date Initiated by Firm |
November 19, 2014 |
| Date Posted |
December 23, 2014 |
| Recall Status1 |
Terminated 3 on June 22, 2015 |
| Recall Number |
Z-0856-2015 |
| Recall Event ID |
69847 |
| Product Classification |
Medical device data system - Product Code OUG
|
| 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. |
| Code Information |
Lot/Serial #(s): N/A Software Version(s): Versions 2.0.0.19 and lower. Expiration Date (s): N/A |
Recalling Firm/
Manufacturer |
Horiba Instruments Inc
9755 Research Dr
Irvine CA 92618-4626
|
| For Additional Information Contact |
949-453-0500
|
Manufacturer 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
|
FDA Determined
Cause 2 |
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. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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