Device product
cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6800/8800 systems support an automated and integrated workflow to run Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) to be applied in diagnostic laboratories.
Z-0107-2017
Product summary
- Event
- Event 75186
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9014 in total
- Official record key
device-enforcement:Z-0107-2017
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.