FDA recall Z-0675-2018

Roche Diagnostics Corporation · Class II · device

Product

Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

Reason for recall

A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect results.

Distribution

Distributed in 36 states: AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI and Puerto Rico.

Key facts

Status: Terminated
Initiation date: 2017-07-28
Report date: 2018-02-28
Termination date: 2020-06-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0675-2018