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

FDA device recall Z-0856-2015 · posted 2014-12-23 · Terminated

Recall details

Recalling firm

Horiba Instruments Inc

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

Action taken

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.

Root cause

Software change control

Status

Terminated

Product code

OUG

Quantity affected

322 (5 in U.S. Military)

Distribution

Nationwide within the U.S.

Date initiated

2014-11-19

Date posted

2014-12-23

Date terminated

2015-06-22

Location

Irvine, CA