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
This recall has been terminated (originally issued October 9, 2020).
- Recall Initiated
- October 9, 2020
- Terminated
- June 9, 2023
- Recall Number
- Z-0461-2021
- Quantity
- 40 licenses
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule
Distribution
Nationwide
Lot / Code Info
Software versions from cobas infinity version 3.00.00 onwards Serial Numbers: 82014 82229 82028 82227 82066 81967 81946 82121 82027 82194 82120 81528 82231 81958 82246 81983 82118 82165 81886 82082 82256 82257 81781 82331 82304 82087 82276 81465 81959 82235 82180 82181 82236 81945 82275 81662 82065 82253 81817 82000
Root Cause
Software design
Action Taken
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.