Home / Recalls / Roche Diagnostics Corporation / Z-0499-2018

Z-0499-2018 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
255 instruments

Product Description

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.

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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