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

Recall date

July 28, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0675-2018

FDA classification

Class II

Brand / firm

Roche Diagnostics Corporation

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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