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