FDA recall Z-2477-2019

Roche Diagnostics Operations, Inc. · Class II · device

Product

Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001

Reason for recall

Quality issue with high pressure solenoid valves

Distribution

State NY MT HI IN MD TX OH KS KY CA FL OR LA MO AK

Key facts

Status: Terminated
Initiation date: 2019-07-18
Report date: 2019-09-11
Termination date: 2020-06-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2477-2019