Roche Diagnostics Corporation recalls Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecs

Recalled February 7, 2018 · FDA recall Z-0499-2018 · 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

255 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

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.

Manufacturer(s)

Roche Diagnostics Corporation

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