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Cobas Recalls
- Starting date:
- October 31, 2012
- Posting date:
- November 26, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15906
Recalled Producst
- Cobas Integra 400 Plus Analyzer
- Cobas Integra 400 Analyzer
- Cobas IT 3000 Software
- Cobas IT Middleware
Reason
The reason for the recall is related to a potential security threat. Oracle announced a critical vulnerability in their TNS-Listener component which is a component of these products. The vulnerability allows attackers to modify the content of a patient database from a remote system.
Affected products
A. Cobas Integra 400 Plus Analyzer
Lot or serial number
N/A
Model or catalog number
03245233001
Companies
- Manufacturer
- Roche Diagnostics Ltd.
B. Analyseur Cobas Integra 400
Lot or serial number
N/A
Model or catalog number
21045199001
Companies
- Manufacturer
- Roche Diagnostics Ltd.
C. Cobas IT 3000 Software
Lot or serial number
N/A
Model or catalog number
05161401001
Companies
- Manufacturer
- Roche Diagnostics Ltd.
D. Intergiciel Cobas IT
Lot or serial number
N/A
Model or catalog number
06498027001
Companies
- Manufacturer
- Roche Diagnostics Ltd.