Recall Z-0461-2021 ยท JQP Calculator/Data Processing Module, For Clinical Use
Roche Diagnostics Operations, Inc.
cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems Catalog Number: 07154003001
| Date | Oct 9, 2020 |
| Status | Terminated |
| Reason | Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule |
| Root cause | Software design |
| Action | Roche issued Urgent Medical Device Correction TP-01100 is on 10/9/20 via UPS Ground (receipt signature required). Letter states reason for recall, health risk and action to take: Until cobas infinity Service Patches are available and implemented at your site, follow the containment measures outlined in the Applying Containment Measures section of this UMDC. " If you run the QC module in the cobas infinity application, contact the Roche Support Network Customer Support Center at 1-800-526-2272, and a representative will run a script to help you determine if your facility might be impacted. " Pl |
| Quantity | 40 licenses |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.