FDA recall Z-0461-2021

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2020-10-09

Report date

2020-11-25

Termination date

2023-06-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0461-2021