STA System - Analyzers (Class 2), STA and STA-R Evolution System - Coagulation System - Prothrombin Time, STA Satellite - Neoplastine CL and Neoplastine CL (Thromboplastin) (2018-07-18)
- Starting date:
- July 18, 2018
- Posting date:
- August 17, 2018
- 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-67412
Affected products
- STA System - Analyzers - Class 2
- STA Coagulation System - Prothrombin Time
- STA-R Evolution System - Coagulation System Prothrombin Time
- STA Satellite - Neoplastine CL
- STA - System - Neoplastine CL (Thromboplastin)
Reason
Notice of QC values falling outside of the assigned ranges (prolonged Prothrombin Time (PT) / decreased PT %) on some vials of the STA - Neoplastine CI Plus 10 mL lot 252450, Stago has investigated and confirmed a performance defect on the concerned lot. The dimensions of the bottle neck on the concerned vials have been found out of specifications (wider), which could create a tightness defect on the freeze dried reagent and thus affect performances.
Affected products
A. STA System - Analyzers - Class 2
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
00667
Companies
- Manufacturer
-
Diagnostica Stago SAS
3 Allée Theresa
Asnières-sur-Seine
92600
FRANCE
B. STA Coagulation System - Prothrombin Time
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
00667
Companies
- Manufacturer
-
Diagnostica Stago SAS
3 Allée Theresa
Asnières-sur-Seine
92600
FRANCE
C. STA-R Evolution System - Coagulation System Prothrombin Time
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
00667
Companies
- Manufacturer
-
Diagnostica Stago SAS
3 Allée Theresa
Asnières-sur-Seine
92600
FRANCE
D. STA Satellite - Neoplastine CL
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
00667
Companies
- Manufacturer
-
Diagnostica Stago SAS
3 Allée Theresa
Asnières-sur-Seine
92600
FRANCE
E. STA - System - Neoplastine CL (Thromboplastin)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
00667
Companies
- Manufacturer
-
Diagnostica Stago SAS
3 Allée Theresa
Asnières-sur-Seine
92600
FRANCE