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Lysercell Wdf
- 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