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

Starting date:

April 10, 2020

Posting date:

May 15, 2020

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-73079

Last updated: 2020-05-15

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  Reason
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  Affected products

Affected Products

1. Sysmex XN-10 Hematology Analyzers
2. Sysmex XN-20 Hematology Analyzers
3. Sysmex XN-11 Hematology Analyzers

Reason

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.

Affected products