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FLUOROCELL PLT (2016-07-01)
- Starting date:
- July 1, 2016
- Posting date:
- August 26, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-59960
Affected Products
FLUOROCELL PLT
Reason
There is a potential that the Fluorescent Platelet (Plt-F) count and Immature Platelet Fraction (IPF %) results performed using Fluorocell Plt lots a5053 or a5054 may exhibit lower than expected Plt-F and IPF values. This reagent is used only on the Sysmex XN-series Hematology Analyzers for the Plt-F and IPF% parameters.
Affected products
FLUOROCELL PLT
Lot or serial number
A5053
A5054
Model or catalog number
CD-994-563
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
JAPAN