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COBAS IT 1000 SOFTWARE (2016-03-30)
- Starting date:
- March 30, 2016
- Posting date:
- April 15, 2016
- 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-57928
Affected products
A. COBAS IT 1000 SOFTWARE
Reason
It was reported that operators/users were unable to access the Accu-Chek Inform II meters after a modification to an expiring certification in cobas IT 1000 version more than (and equal to) 2.01.00.
Affected products
A. COBAS IT 1000 SOFTWARE
Lot or serial number
Version 2.04.01
Version 2.06.00
Model or catalog number
04420306001
04481763001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY