System Control N+P, STA - Coag Control N+P & Unicalibrator - STA (2019-11-19)
- Starting date:
- November 19, 2019
- Posting date:
- December 13, 2019
- 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-71861
Last updated: 2019-12-13
Affected Products
- System Control N+P, STA - Coag Control N+P
- Unicalibrator, STA
Reason
Following a customer complaint, Stago has investigated and confirmed that a positive bias exists on the STA - Unicalibrator levels with STA - deficient IX and STA - deficient VIII when compared to the international Standard (IS) for factor VIII or IX. This bias is also observed on several external quality assessment results.
Affected products
A. System Control N+P, STA - Coag Control N+P
Lot or serial number
253145
253416
253655*
254040*
254206
254401
254573
254760
Model or catalog number
678
Companies
- Manufacturer
-
Diagnostica Stago SAS
9, Rue Des Freres Chausson
Asnieres
92600
FRANCE
B. Unicalibrator, STA
Lot or serial number
253180
253964
254721
255108
Model or catalog number
675
Companies
- Manufacturer
-
Diagnostica Stago SAS
9, Rue Des Freres Chausson
Asnieres
92600
FRANCE