FDA-Device2018-04-04Class II
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).
Roche Diagnostics Corporation
Hazard
Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters.
Sold states
US Nationwide
Manufactured in
9115 Hague Rd, Indianapolis, IN, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1270-2018Don't want to check this manually?
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