Product Wiki · Recalls · Health Canada — Medical Devices

Sysmex XN-10, XN-20 & XN-11 Hematology Analyzers (2020-04-10) — recall 61252

Health Canada — Medical Devices · Canada · 2020-05-15 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
61252
Date of alert
2020-05-15
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Sysmex Corporation, Japan (S-Corp.) notified Sysmex America, Inc. (SAI) that they are implementing a leak detector sensor on all XN Series analyzers. The tray catches leaking reagent and the sensor disables the analyzer if a malfunction causing diluent leakage is detected. If fluid is collected in the tray, the user is informed with an error message "Water leak detected (analysis not possible)" and the Action to "Turn off the Main power and check the analyzer." New analyzers for all models are manufactured with the tray and sensor, but all installed analyzers will be retrofitted with the tray and sensor in this correction.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/sysmex-xn-10-xn-20-xn-11-hemat

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