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VISUCON-F LOW FIBRINOGEN CONTROL PLASMA (2015-03-13)
- Starting date:
- March 13, 2015
- Posting date:
- April 2, 2015
- 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-52765
Recalled Products
VISUCON-F LOW FIBRINOGEN CONTROL PLASMA
Reason
Our instructions for use for this product indicate that we will report an assigned range for Fibrinogen on the accompanying certificate of analysis (COA). For the two lots identified in this recall only a mean value was reported on the COA. It was determined a recall would be initiated to notify customers of this omission and provide them with an updated certificate of analysis.
Affected products
VISUCON-F LOW FIBRINOGEN CONTROL PLASMA
Lot or serial number
- 0003-71FCP
- 0004-71FCP
Model or catalog number
- LFGCP0105
- LFGCP0125
- LFGCP0181
Companies
- Manufacturer
-
Affinity Biologicals Inc.
1395 Sandhill Drive
Ancaster
L9G 4V5
Ontario
CANADA