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Cobas MPX
- Starting date:
- May 15, 2017
- Posting date:
- July 17, 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-63944
Reason
Following internal investigation, the manufacturer identified a situation where under specific conditions, there is a possibility that target specific results sent to a customer laboratory information system (LIS) may not match those results displayed on the Cobas 6800-8800 user interface (UI).
Affected products
Cobas MPX
Lot or serial number
222194
Model or catalog number
06997708190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY