FDA recall Z-0922-2020

Roche Diagnostics Operations, Inc. · Class II · device

Product

Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001

Reason for recall

Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver - Incorrect Alarm Mapping

Distribution

US Nationwide in the states of AL, CA, GA, IA, IL, KY, MI, MO, MT, NJ, NY, OR, TN

Key facts

Status
Terminated
Initiation date
2019-10-08
Report date
2020-02-05
Termination date
2020-10-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0922-2020