Device product
cobas p 471 centrifuge unit calculator/data processing module, for clinical use Product Usage: The cobas p312 pre-analytical system is a computer controlled stand-alone system for sorting and decapping sample tubes. As an option, the system works with an online connection.
Z-0108-2017
Product summary
- Event
- Event 75186
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9014 in total
- Official record key
device-enforcement:Z-0108-2017
Official wording
Reason: Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
Code information: Not applicable
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.