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Roche COBAS INTEGRA 400 and 400 plus Analyzer recallZ-0696-2013 · Roche Diagnostics Operations, Inc. · initiated Nov 19, 2012

Class III Terminated All recalls posted in January 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Roche Diagnostics Operations, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-0696-2013
Recall class
Class III
Status
Terminated
Initiated by the company
Nov 19, 2012
Posted by the FDA
Jan 18, 2013
Recalling firm
Roche Diagnostics Operations, Inc.
Quantity
845 Units
Product code
JJE
FDA submissions
K951595
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.

Product description

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

Code information (models, lots, serial numbers)

Part Numbers: 28065047001 and 03245233001

Other devices under the same FDA submission

11 devices cleared under K951595 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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