COBAS 6800, 8800 (2019-06-13)
- Starting date:
- June 13, 2019
- Posting date:
- July 19, 2019
- 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-70439
Last updated: 2019-07-19
Affected Products
A. COBAS 6800
B. COBAS 8800
Reason
The processing transfer heads can, in certain conditions, leak on the processing module deck, heating station and separation station, which could cause invalid results, false positives or over-quantified results as a consequence of cross contamination of samples.
Affected products
A. COBAS 6800
Lot or serial number
All lots.
Model or catalog number
5524245001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. COBAS 8800
Lot or serial number
All lots.
Model or catalog number
5412722001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY