Sysmex XN-L Series (2017-12-01)

Starting date:

December 1, 2017

Posting date:

January 8, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-65566

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  Reason
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  Affected products

Affected Products

Sysmex XN-L Series

Reason

After the change to standard time from Daylight Savings Time, the analyzer's time may not be consistent with local time. The analyzer date may also not reflect the current date. The discrepancy is due to a time difference between the windows operating system and the XN-L program time. After changing the time and date in the analyzer's software and cycling power to the analyzer, the date and time may not be correct when the analyzer restarts. Patient and Quality Control (QC) results are not impacted. However, the analysis date and time displayed, printed and transmitted with the results may not reflect the actual date and time the sample was run.

Affected products