FDA-Device2020-11-25Class II
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
Roche Diagnostics Operations, Inc.
Hazard
Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule
Sold states
Nationwide
Affected count
40 licenses
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0461-2021Don't want to check this manually?
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