FDA-Device2018-04-04Class II
c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692
Roche Diagnostics Corporation
Hazard
Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters.
Sold states
US Nationwide
Manufactured in
9115 Hague Rd, Indianapolis, IN, United States
Products
c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1268-2018Don't want to check this manually?
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