FDA Enforcement
Class II
Terminated
cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer Product Usage: The VS II system is a stand-alone, computer-controlled instrument designed to aliquot patient sample from a primary tube to a barcoded secondary tube for processing on an off-line analyzer.
Recall: Z-0097-2017
·
Reported November 2, 2016
Enforcement
- Recall Number
- Z-0097-2017
- 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
cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer Product Usage: The VS II system is a stand-alone, computer-controlled instrument designed to aliquot patient sample from a primary tube to a barcoded secondary tube for processing on an off-line analyzer.
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