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Cobas B221 - Reference Electrode (2014-01-31)
- Starting date:
- January 31, 2014
- Posting date:
- March 18, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-38337
Recalled Products
Cobas B221 - Reference Electrode
Reason
The Cobas B221 reference electrode has a lifetime of 52 weeks but is not documented in the analyzer manual. Customers had not been sufficiently informed regarding this limitation. They may find themselves using aged electrodes leading to leakage. Ultimately, this may cause a pH and a NA+ offset which may result by incorrect diagnosis and treament.
Affected products
Cobas B221 - Reference Electrode
Lot or serial number
All lots
Model or catalog number
3111873180
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY