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

Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule

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. " Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. " Complete the attached faxback form (TP-01111) and fax or email it according to the instructions on the form. " File this Urgent Medical Device Correction (UMDC) for future reference. The cobas infinity Service Patches 3.01.12 (to correct affected versions 3.01.xx) and 3.02.05 (to correct affected versions 3.02.xx) are planned to be available in the fourth quarter of 2020. Once the Services Patches are available, a Roche Diagnostics representative will contact you to coordinate the corresponding installation.