Recall Z-0696-2013— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-0696-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-19

Class III · Terminated

Class III FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2012-11-19, terminated 2014-01-13. It names one FDA 510(k) clearance: K951595. Product: Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.. Reason: A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener is supplied with the Roche COBAS INTEGRA 400/400 plus Analyzers. The Oracle TNS-Listener can be considered as an authentication and redirection component between the client and the database inside the Roche product. This means an attacker could register their own non-Roche database via remote access.

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class III
Status: Terminated
Initiated: 2012-11-19
Terminated: 2014-01-13
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K951595 — ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTESRoche Diagnostic Systems, Inc.·cleared 1995-09-08

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

Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.

Reason for recall

A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener is supplied with the Roche COBAS INTEGRA 400/400 plus Analyzers. The Oracle TNS-Listener can be considered as an authentication and redirection component between the client and the database inside the Roche product. This means an attacker could register their own non-Roche database via remote access

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