Company: Roche Molecular Systems, Inc.
Date of Enforcement Report 12/19/12
Class ll:
PRODUCT
DataCare GM DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
Recall Number Z-0492-2013
REASON
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+ .
RECALLING FIRM/MANUFACTURER
Roche Molecular Systems, Inc. Branchburg, NJ on 6/25/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
479 units
DISTRIBUTION
Nationwide
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