Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
Check against the official notice below — it lists the full affected range.
Roche Diagnostics Operations, Inc. is recalling the Roche COBAS INTEGRA 400 and 400 plus Analyzer due to a software security issue with Oracle's TNS-Listener component. The TNS-Listener functions as an authentication and redirection component between the client and the database within the product. This vulnerability could potentially allow an attacker to register their own non-Roche database via remote access. A total of 845 units have been distributed nationwide across the United States and Puerto Rico, with Part Numbers 28065047001 and 03245233001.
The recall affects in vitro diagnostic analyzers distributed throughout all 50 states and the territory of Puerto Rico. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 Distribution: 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. Quantity: 845 Units Lot/code info: Part Numbers: 28065047001 and 03245233001
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.