Roche Diagnostics Corporation recalls cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system)

Recalled February 7, 2018 · FDA recall Z-0498-2018 · Roche Diagnostics

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. · FDA Class II

Units

923 instruments

Sold at

Nationwide Distribution

Description

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.

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.

Manufacturer(s)

Roche Diagnostics Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →