Home / Recalls / Roche Diagnostics Corporation / Z-0498-2018

Z-0498-2018 Class II Terminated

Recalled by Roche Diagnostics Corporation — Indianapolis, IN

Recall Details

Product Type
Devices
Report Date
February 7, 2018
Initiation Date
July 5, 2017
Termination Date
April 30, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
923 instruments

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Nationwide Distribution

Code Information

none

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