Device product

cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system) & 04775279973 (disk system).

Z-1270-2018

December 18, 2017

Class II

Product summary

Firm: Roche Diagnostics Corporation
Event: Event 79074
Status: Terminated
Classification: Class II
Quantity: Unavailable
Official record key: device-enforcement:Z-1270-2018

Official wording

Reason: Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters.

Code information: None

Distribution pattern: US Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters.