Recall Z-0675-2018— Roche Diagnostics Corporation

Name: FDA recall Z-0675-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-28

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Corporation, initiated 2017-07-28, terminated 2020-06-10. It names one FDA 510(k) clearance: K100853. Product: Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001. Reason: A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect results..

Recalling firm: Roche Diagnostics Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-07-28
Terminated: 2020-06-10
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K100853 — COBAS 8000 MODULAR SERIES ANALYZERRoche Diagnostics Corp.·cleared 2010-09-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.