FDA Enforcement
Class II
Terminated
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.
Recall: Z-0100-2017
·
Reported November 2, 2016
Enforcement
- Recall Number
- Z-0100-2017
- Event ID
- 75186
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Roche Diagnostics Operations, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 2, 2016
- Initiation Date
- July 15, 2016
- Classification Date
- October 25, 2016
- Termination Date
- June 5, 2017
- Address
- 9115 Hague Rd, Indianapolis, IN, 46256-1025, United States
Description
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.
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 Info
Not applicable
Distribution
US Nationwide Distribution
Quantity
9014 in total