FDA-Device2018-02-28Class II
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
Roche Diagnostics Corporation
Hazard
A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect results.
Sold states
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.
Affected count
399
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0675-2018Don't want to check this manually?
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