Recall Z-0498-2018 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Roche Diagnostics Corporation
cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04775201973 - cobas e 411 analyzer (rack system), medial device listing number: E116019 cobas e 411 Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body
| Date | Jul 5, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | 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 ba |
| Quantity | 923 instruments |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.