STA Coagulation System - Prothrombin Time, STA-R Evolution System - Coagulation System Prothrombin Time, and STA Satelllite - Neoplastine CI (2017-10-25)

Starting date:

October 25, 2017

Posting date:

December 21, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Hospitals, General Public, Healthcare Professionals

Identification number:

RA-65496

• Reason
• Affected products

Affected products

1. STA Coagulation System - Prothrombin Time
2. STA-R Evolution System - Coagulation System Prothrombin Time
3. STA Satelllite - NEOPLASTINE CI

Reason

Following customer complaints, Stago has investigated on a potential defect of homogeneity within lot and had confirmed a performance defect on a small number of vials for some lots STA - Neoplastine CI Plus. Indeed, for these lots, some vials give longer clotting times than expected (decreased pt %). No complaints have been received from Canadian customers.

Affected products