Company:Roche Diagnostics Corporation
Date of Enforcement Report 2/7/2018
Class lI:
PRODUCT
cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 – cobas e 411 analyzer (disk system) and 04775201001/04775201973 – cobas e 411 analyzer (rack system), medial device listing number: E116019 cobas e 411 Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.
Recall Number Z-0498-2018
REASON
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.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corporation, Indianapolis, IN on 7/5/2017. Voluntary firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
923 instruments
DISTRIBUTION
Nationwide
___________________________________
