FDA Medical Device Recalls (openFDA)
Roche Diagnostics Operations, Inc.: Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
- Recall number
- Z-0696-2013
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Product
- Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
- Status
- Terminated
- Initiated
- 2012-11-19
- Posted
- 2013-01-18
- Terminated
- 2014-01-13
- 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
- Root cause
- Software design
- Action
- Roche sent an Urgent Medical Device Correction letter on November 19, 2012, to all affected customers via UPS Ground (receipt required). The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the attached form and return by fax and file this Medical Device Correction for future reference. For technical support customers were instructed to contact Diagnostics Technical Support at 1-900-428-2336. For questions regarding this recall call 317-521-3911.
- 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.
- Lot, serial or model codes
- Part Numbers: 28065047001 and 03245233001
- 510(k) numbers
- ["K951595"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28