FDA-Device2018-02-07Class II
Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244 - Elecsys 2010 Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.
Roche Diagnostics Corporation
Hazard
A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.
Sold states
Nationwide Distribution
Affected count
255 instruments
Manufactured in
9115 Hague Rd, Indianapolis, IN, United States
Products
Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244 - Elecsys 2010 Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0499-2018Don't want to check this manually?
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