This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Cobas IT 1000 Software (2014-05-02)
- Starting date:
- May 2, 2014
- Posting date:
- July 3, 2014
- 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-40301
Recalled Products
Cobas IT 1000 Software
Reason
The Cobas IT1000 data manager software system could cause duplication of results when used in combination with the radiometer ABL 80 driver (v 1.0.4).
Affected products
Cobas IT 1000 Software
Lot or serial number
All serial numbers
Model or catalog number
04420306001
04481763001
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY