FDA Enforcement
Class II
Terminated
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: Z-0499-2018
·
Reported February 7, 2018
Enforcement
- Recall Number
- Z-0499-2018
- Event ID
- 78756
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Roche Diagnostics Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 7, 2018
- Initiation Date
- July 5, 2017
- Classification Date
- February 1, 2018
- Termination Date
- April 30, 2019
- Address
- 9115 Hague Rd, Indianapolis, IN, 46256-1025, United States
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
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 Info
none
Distribution
Nationwide Distribution
Quantity
255 instruments