—#184190

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

FDA product code: JQP — Calculator/Data Processing Module, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected 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

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2020-10-09
Terminated: 2023-06-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184190. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.