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Roche Diagnostics Operations, Inc. recalls cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be use
Recalled November 25, 2020 · FDA recall Z-0461-2021 · Roche Diagnostics Operations
Hazard
Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule · FDA Class II
Units
40 licenses
Sold at
Nationwide
Description
Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule
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
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →