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Lysercell Wdf

Report a Concern
Starting date:
July 26, 2017
Posting date:
August 15, 2017
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-64230

Reason

Sysmex reports a performance issue related to specific lots of Lysercell WDF Reagent used on XN and XN-L series instruments. When using the affected lots, some customers have experienced an increase in false positive differential flags on patient samples. Reportable results from the instrument were not affected.

Affected products

Lysercell Wdf

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

ZA900001

Companies

Manufacturer
Sysmex Reagents America
Two Nelson C White Parkway
Mundelein
60060
UNITED STATES