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Cobas P612 and P512 Pre-Analytical Systems (2017-05-31)
- Starting date:
- May 31, 2017
- Posting date:
- June 21, 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-63668
Affected Products
A. Cobas P612 Pre-Analytical System
B. Cobas P512 Pre-Analytical System
Reason
Following internal investigation, the manufacturer identified a situation where under specific conditions, there is a possibility that un-spun samples could be incorrectly identified as spun by the spin status detection configuration of the Cobas P512-P612 pre-analytical system when used in combination with dynamic interface system.
Affected products
A. Cobas P612 Pre-Analytical System
Lot or serial number
Not Applicable
Model or catalog number
7563116001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. Cobas P512 Pre-Analytical System
Lot or serial number
Not applicable
Model or catalog number
7563124001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY