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Visudep-F Frozen Factors Deficient Plasma (2017-08-29)
- Starting date:
- August 29, 2017
- Posting date:
- September 26, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-64556
Affected Products
- Visudep-F Frozen Factor V Deficient Plasma
- Visudep-F Frozen Factor VII Deficient Plasma
- Visudep-F Frozen Factor IX Deficient Plasma
- Visudep-F Frozen Factor VIII Deficient Plasma
- Visudep-F Frozen Factor X Deficient Plasma
- Visudep-F Frozen Factor XI Deficient Plasma
- Visudep-F Frozen Factor XII Deficient Plasma
Reason
Affinity Biologicals has determined that there was an error in the dilution factors provided in the preparation of the calibration curve section of the IFU (instructions for use) provided with these products.
The provided dilution factors were: 1/10, 1/20, 1/40, 1/180, 1/160.
The correct dilution factors are: 1/10, 1/20, 1/40, 1/80, 1/160.
This is a typographical error only, the description and volumes listed in the table preparation of calibration curve dilutions are correct.
Affected products
A. Visudep-F Frozen Factor V Deficient Plasma
Lot or serial number
- 0004-5FDP
- 0005-5FDP
- 0006-5FDP
Model or catalog number
- FRDP050105
- FRDP050125
Companies
- Manufacturer
-
Affinity Biologicals Inc.
1395 Sandhill Drive
Ancaster
L9G 4V5
Ontario
CANADA
B. Visudep-F Frozen Factor VII Deficient Plasma
Lot or serial number
- 0004-7FDP
- 0005-7FDP
- 0006-7FDP
Model or catalog number
- FRDP070105
- FRDP070125
Companies
- Manufacturer
-
Affinity Biologicals Inc.
1395 Sandhill Drive
Ancaster
L9G 4V5
Ontario
CANADA
C. Visudep-F Frozen Factor IX Deficient Plasma
Lot or serial number
- 0004-9FDP
Model or catalog number
- 0004-9FDP
Companies
- Manufacturer
-
Affinity Biologicals Inc.
1395 Sandhill Drive
Ancaster
L9G 4V5
Ontario
CANADA
D. Visudep-F Frozen Factor VIII Deficient Plasma
Lot or serial number
- 0005-8FDP
Model or catalog number
- FRDP080125
Companies
- Manufacturer
-
Affinity Biologicals Inc.
1395 Sandhill Drive
Ancaster
L9G 4V5
Ontario
CANADA
E. Visudep-F Frozen Factor X Deficient Plasma
Lot or serial number
- 0004-10FDP
- 0005-10FDP
Model or catalog number
- FRDP100105
- FRDP100125
Companies
- Manufacturer
-
Affinity Biologicals Inc.
1395 Sandhill Drive
Ancaster
L9G 4V5
Ontario
CANADA
F. Visudep-F Frozen Factor XI Deficient Plasma
Lot or serial number
- 0005-11FDP
Model or catalog number
- FRDP110105
- FRDP110125
Companies
- Manufacturer
-
Affinity Biologicals Inc.
1395 Sandhill Drive
Ancaster
L9G 4V5
Ontario
CANADA
G. Visudep-F Frozen Factor XII Deficient Plasma
Lot or serial number
- 0004-12FDP
- 0005-12FDP
Model or catalog number
- FRDP120105
- FRDP120125
Companies
- Manufacturer
-
Affinity Biologicals Inc.
1395 Sandhill Drive
Ancaster
L9G 4V5
Ontario
CANADA