FDAJuly 5, 2017device
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 full...
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
roche diagnosticsroche
UPCs
11568248001115682486921180401400111804014692
Recall history
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