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Ceruloplasmin for Roche/Hitachi COBAS C Analyzers
- Starting date:
- December 6, 2016
- Posting date:
- January 6, 2017
- 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-61574
Reason
During an internal investigation the Ceruloplasmin Assay (Cat 20764663322 Lot 19395501/only lot imported in Canada) will need to have the sensitivity limit parameter changed when used on the Cobas C311/C501/C502/C701/C702 until further notice. Higher signals could be generated causing problems with the upper sensitivity limit that could generate error alarms that would prevent performing any measurements.
Affected products
Ceruloplasmin for Roche/Hitachi COBAS C Analyzers
Lot or serial number
19395501
Model or catalog number
20764663322
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY