Company: Roche Diagnostics Operations, Inc.
Date of Enforcement Report: 11/25/2020
Class II

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

Recall Number: Z-0461-2021

REASON

Potential incorrect validation of results due to an erroneous QC status when using status expiration control rule.

RECALLING FIRM/MANUFACTURER

Roche Diagnostics Operations, Inc. on 10/9/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

40 licenses

DISTRIBUTION

U.S. Nationwide