Sysmex XN-10 Hematology Analyzer (2019-01-14)

Starting date:

January 14, 2019

Posting date:

January 31, 2019

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-68962

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  Reason
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  Affected products

Affected Products

Sysmex XN-10 Hematology Analyzer

Reason

Sysmex has identified a defect in the shielding used for the flow cytometry module (FCM) detector wiring harness in certain XN-10 analyzers. Improper shielding of the FCM detector may result in abnormal scattergram patterns and increased flagging. Numeric results are not affected.

Affected products