Enforcement Report - Week of December 19, 2012
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Product Detail
| Product Description | cobas® 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. |
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| Recall Number | Z-0490-2013 |
| Classification | Class II |
| Code Info | cobas® 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 |
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