Roche Diagnostics Operations, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0696-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: November 19, 2012

Date Posted: January 30, 2013

Recall Number: Z-0696-2013

Event ID: 63617

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

Status: Terminated

Product Quantity: 845 Units

Code Information:

Part Numbers: 28065047001 and 03245233001

Distribution Pattern:

Nationwide Distribution including AL, AR, AZ, CA, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR.

Voluntary or Mandated:

Voluntary: Firm initiated