Roche COBAS INTEGRA 400 and 400 plus Analyzer recall: Software Issue
Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
Why was Roche COBAS INTEGRA 400 and 400 plus Analyzer recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Numbers: 28065047001 and 03245233001
- Product
- Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 845 Units
- 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.
- Recall date
- January 30, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)