Cobas e411 Immunoassay Analyzer (2018-09-24)
- Starting date:
- September 24, 2018
- Posting date:
- October 19, 2018
- 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-67948
Affected products
Cobas e411 Immunoassay Analyzer
Reason
Following investigation of customer complaints, the manufacturer changed the frequency interval for mandatory replacement of pinch valve tubing in order to avoid the risk to obtain potential too high results or out of the measuring range results.
Affected products
Cobas e411 Immunoassay Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 04775201001
- 04775279001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY