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U.S. Department of Health and Human Services

Class 2 Device Recall Roche cobas infinity central lab/core license

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  Class 2 Device Recall Roche cobas infinity central lab/core license see related information
Date Initiated by Firm October 09, 2020
Create Date November 17, 2020
Recall Status1 Terminated 3 on June 09, 2023
Recall Number Z-0461-2021
Recall Event ID 86609
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product 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
Code Information 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  
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Roche Customer Support Center
800-428-2336
Manufacturer Reason
for Recall		 Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule
FDA Determined
Cause 2		 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. " 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.
Quantity in Commerce 40 licenses
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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