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Screen-Cyte 0.8% Reagent Red Blood Cells
- Starting date:
- June 23, 2017
- Posting date:
- July 17, 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-63978
Reason
The manufacturer, Medion Grifols Diagnostics, AG, has become aware through their routine vigilance process, that the antigen table provided with this product contains an error. The error affects the Lub antigen in the first cell (donor 0124624) of the screen-cyte 0.8% and screen-cyte p 0.8% antigen panels, Lot 17011. Specifically, the table shows that cell 1 has a negative typing "0" for Lub antigen while the actual value is positive "+."
Affected products
Screen-Cyte 0.8% Reagent Red Blood Cells
Lot or serial number
17011
Model or catalog number
213590
213665
Companies
- Manufacturer
-
Medion Grifols Diagnostics AG
Bonnstrasse 9
Dudingen
3186
SWITZERLAND