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VisuCon-F Frozen Abnormal Control Plasma (2016-06-23)
- Starting date:
- June 23, 2016
- Posting date:
- June 30, 2016
- 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-59126
Affected products
A. VisuCon-F Frozen Abnormal Control Plasma
Reason
The certificate of analysis (COA) for lot 0007-53FCP reports the incorrect range for Protein C due to a calculation error.
Reported range : 34-46%
Actual range : 34-48%
Affected products
A. VisuCon-F Frozen Abnormal Control Plasma
Lot or serial number
0007-53FCP
Model or catalog number
FRABP0105
FRABP0125
Companies
- Manufacturer
-
Affinity Biologicals Inc.
1395 Sandhill Drive
Ancaster
L9G 4V5
Ontario
CANADA