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Cobas MPX
- Starting date:
- February 13, 2017
- Posting date:
- February 28, 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-62422
Reason
Following internal investigation of customer complaints, the manufacturer identified a situation where the Cobas 6800/8800 MPX Reagent Kit (Lot 222194) was incorrectly packaged within a kit carton labelled as MPX Control Kit. Only a few kits were presenting the erroneous label. There is no impact on the test performance and the reagent cannot be incorrectly used on the instrument.
Affected products
Cobas MPX
Lot or serial number
222194
Model or catalog number
06997708190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY