FDA-Device2018-04-04Class II
Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 03023109001, 05023599001, 05023572001, 03739040001 & 03023109973.
Roche Diagnostics Corporation
Hazard
Complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters.
Sold states
US Nationwide
Manufactured in
9115 Hague Rd, Indianapolis, IN, United States
Products
Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 03023109001, 05023599001, 05023572001, 03739040001 & 03023109973.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1269-2018Don't want to check this manually?
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