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.
This recall has been terminated (originally issued July 5, 2017).
- Company
- Roche Diagnostics Corporation
- Recall Initiated
- July 5, 2017
- Terminated
- April 30, 2019
- Recall Number
- Z-0499-2018
- Quantity
- 255 instruments
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide Distribution
Lot / Code Info
none
Root Cause
Software design
Action Taken
All consignees were notified by Urgent Medical Device Correction sent via UPS Ground (receipt required) on July 5, 2017. The customer is advised to perform the following actions: cobas e 411: Until the software update is available, use the workaround outlined in the Urgent Medical Device Correction (UMDC). Elecsys 2010: Use the workaround outlined in this Urgent Medical Device Correction (UMDC). Non-responding accounts will be defined as users for which confirmation of receipt of the Urgent Medical Device Correction (UMDC) cannot be obtained. These accounts will be monitored on an ongoing basis and follow-up attempts will be made accordingly. Workaround for customers: he customer is advised to perform the following actions: cobas e 411: Until the software update is available, use the workaround outlined in the Urgent Medical Device Correction (UMDC). Elecsys 2010: Use the workaround outlined in this Urgent Medical Device Correction (UMDC). For further questions, please call (317) 521-7259