Device 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.
Z-0499-2018
Product summary
- Event
- Event 78756
- Status
- Terminated
- Classification
- Class II
- Quantity
- 255 instruments
- Official record key
device-enforcement:Z-0499-2018
Official wording
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.
Code information: none
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Device software or design
software malfunction