Moderate FDA (Devices)·Z-0696-2013·Announced 2013-01-30

Roche COBAS INTEGRA 400 Analyzer Recalled for Software Security Issue

Roche is recalling COBAS INTEGRA 400 analyzers due to a security vulnerability in the Oracle TNS-Listener component that could allow unauthorized database access.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard is a software security vulnerability rather than a direct physical or biological health risk, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling 845 units of the Roche COBAS INTEGRA 400 and 400 plus Analyzer. These are in vitro diagnostic analyzers distributed nationwide, including in 41 states, the District of Columbia, and Guaynabo, Puerto Rico.

The recall is due to a software security issue identified in the Oracle TNS-Listener component supplied with the analyzers. TNS-Listener functions as an authentication and redirection component between the client and the internal database. The vulnerability means an attacker could potentially register their own non-Roche database via remote access.

Healthcare facilities and users of these analyzers should contact Roche Diagnostics Operations, Inc. for instructions on how to address the security issue. The affected units are identified by Part Numbers 28065047001 and 03245233001.

The recalled product

Product: Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
Manufacturer: Roche Diagnostics Operations, Inc.
Category: Medical Device — In Vitro Diagnostic Analyzer
Hazard: software-security
Affected units: 845

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Part Numbers: 28065047001 and 03245233001

Distribution

Distributed nationwide across the United States.

The notice also names 45 states specifically:

Same manufacturer · Roche Diagnostics Operations, Inc.

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