FDA-Device2014-06-25Class II
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
Roche Diagnostics Operations, Inc.
Hazard
Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.
Sold states
US Nationwide Distribution
Affected count
462
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1790-2014Don't want to check this manually?
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