COBAS INTEGRA 400 plus Analyzer, COBAS C 111 Stand Alone Configuration and COBAS C 111 with ISE Stand Alone Configuration (2018-12-10)
- Starting date:
- December 10, 2018
- Posting date:
- January 9, 2019
- 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-68662
Affected products
- COBAS INTEGRA 400 plus Analyzer
- COBAS C 111 Stand Alone Configuration
- COBAS C 111 with ISE Stand Alone Configuration
Reason
Different types of carryover were discovered concerning the COBAS INTEGRA 400 plus (cat # 03245233001) and the COBAS C111 analyzers (cat # 04777433001/ 04528778001).
Affected products
A. COBAS INTEGRA 400 plus Analyzer
Lot or serial number
All serial numbers.
Model or catalog number
03245233001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. COBAS C 111 Stand Alone Configuration
Lot or serial number
All serial numbers.
Model or catalog number
04528778001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
C. COBAS C 111 with ISE Stand Alone Configuration
Lot or serial number
All serial numbers.
Model or catalog number
04777433001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY