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Cobas 8100 BRF System
- Starting date:
- February 23, 2017
- Posting date:
- April 13, 2017
- 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-62954
Reason
Following internal investigation of a customer complaint, the manufacturer identified a situation where the Cobas 8100 System Reformatter Module BRF SW Version 02-XX may cause sample racks crash potentially leading to be shaken and specimen to be spilled. There could be an impact on the test performance since a cross-contamination cannot be excluded and could lead to erroneous results. The manufacturer advised us of this on 20-Feb-2017.
Affected products
Cobas 8100 BRF System
Lot or serial number
Version 02-XX
Model or catalog number
MODULE BRF SW
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY