STA - ImmunoDef VIII and STA-Deficient VIII (2020-03-05)
- Starting date:
- March 5, 2020
- Posting date:
- April 15, 2020
- 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-72725
Last updated: 2020-04-15
Affected Products
- STA - ImmunoDef VIII
- STA - Deficient VIII
Reason
Following the recent introduction to the market of the Emicizumab prescription treatment for hemophilia A (trade name Hemlibra, marketed by Genentech USA Inc./A member of the Roche Group), Stago has detected a risk to factor VIII assays on Stago instruments: STA-R® Max, STA-R® Evolution, STA® Compact Max, and STA® Compact.
Affected products
A. STA - ImmunoDef VIII
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
728
Companies
- Manufacturer
-
Diagnostica Stago SAS
9, Rue Des Freres Chausson
Asnieres
92600
FRANCE
B. STA - Deficient VIII
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
725
Companies
- Manufacturer
-
Diagnostica Stago SAS
9, Rue Des Freres Chausson
Asnieres
92600
FRANCE