Device product
Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612 is a computer-controlled stand-alone system for aliquoting and sorting of barcoded sample tubes. The system operates with an online connection to the host.
Z-0100-2017
Product summary
- Event
- Event 75186
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9014 in total
- Official record key
device-enforcement:Z-0100-2017
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.