Device product
c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692
Z-1268-2018
Product summary
- Event
- Event 79074
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1268-2018
Official wording
Reason: Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters.
Code information: None
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters.