Cobas IT Middleware (2019-07-26)
- Starting date:
- July 26, 2019
- Posting date:
- August 16, 2019
- 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-70735
Last updated: 2019-08-16
Affected Products
Cobas IT Middleware
Reason
A situation was identified describing a potential situation for the cobas IT Middleware (cat # 06498027001 and 06498035001, SW versions 1.09.00, 1.09.01 And 1.10.00) To have patient results that could be sent without QC validation in very specific conditions.
Affected products
Cobas IT Middleware
Lot or serial number
software version: 1.09.00
software version: 1.09.01
software version: 1.10.00
Model or catalog number
6498027001
6498035001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY