Home / Recalls / Medical Devices
Roche Diagnostics Corporation recalls Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
Recalled February 28, 2018 · FDA recall Z-0675-2018 · Roche Diagnostics
Hazard
A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect results. · FDA Class II
Units
399
Sold at
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.
Description
A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect results.
Product
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
Manufacturer(s)
Roche Diagnostics Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →