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

FDA device recall Z-0696-2013 · posted 2013-01-18 · Terminated

Recall details

Recalling firm

Roche Diagnostics Operations, Inc.

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

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

JJE

Quantity affected

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

Date initiated

2012-11-19

Date posted

2013-01-18

Date terminated

2014-01-13

Location

Indianapolis, IN

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