Recall Z-1792-2014— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-1792-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-21

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2014-05-21, terminated 2015-06-04. It names one FDA 510(k) clearance: K060373. Product: cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.. Reason: Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms..

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-05-21
Terminated: 2015-06-04
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K060373 — COBAS 6000 SERIES SYSTEMRoche Diagnostics·cleared 2006-03-13

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 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

Reason for recall

Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.

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