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U.S. Department of Health and Human Services

Enforcement Report - Week of December 19, 2012

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Product Detail

Product Description cobasĀ® Integra 400/400 Plus (Software version 3.4) The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
Recall Number Z-0490-2013
Classification Class II
Code Info cobasĀ® Integra 400/400 Plus (Software version 3.4)
Product Distributed Qty 855 units.
Reason For Recall Symantec, a third party software vendor, informed Roche about a defect in their pcAnywhere software (versions 12.6.6 and older), which is a software product for accessing PCs remotely. The defect is a "pre authentication vulnerability" which allows hackers to gain full access to the target system without having to log on. The following Roche products are potentially affected by this issue: AMPLILINK Data Station, MagNA Pure LC, MagNA Pure 96 Instrument IVD, LightCycler 1.2 Instrument, LightCycler 2.0 Instrument, cobas 8000, Instrument Manager, DataCare GM, DataCare POC and COBAS INTEGRA 400/400+ .

Event Detail

Event Id 63312
Product Type Devices
Status Ongoing
Recalling Firm Roche Molecular Systems, Inc.
City Branchburg
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-25
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution