Recall Z-0910-2018— Roche Diagnostics Corporation

Name: FDA recall Z-0910-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-18

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Corporation, initiated 2017-07-18, terminated 2018-07-13. It names one FDA 510(k) clearance: K100853. Product: cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module. Reason: A warning is being added to the cobas¿ 6000 analyzer and the cobas¿ 8000 modular analyzer series Operators Manual to prevent operator injury during maintenance..

Recalling firm: Roche Diagnostics Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-07-18
Terminated: 2018-07-13
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 Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module

Reason for recall

A warning is being added to the cobas¿ 6000 analyzer and the cobas¿ 8000 modular analyzer series Operators Manual to prevent operator injury during maintenance.

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