Product Wiki · Recalls · Health Canada — Medical Devices

Sysmex XN-L Series (2017-12-01) — recall 58014

Health Canada — Medical Devices · Canada · 2018-01-08 · Type III

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
58014
Date of alert
2018-01-08
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/sysmex-xn-series-2017-12-01

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.