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

• 
  Reason
• 
  Affected products

Affected Products

1. STA - ImmunoDef VIII
2. 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