Company:Roche Diagnostics Corporation
Date of Enforcement Report 2/7/2018
Class lI:

PRODUCT

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.
Recall Number Z-04992018

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
255 instruments

DISTRIBUTION
Nationwide

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