Company: Roche Molecular Systems, Inc.
Date of Enforcement Report 12/19/12
Class ll:
PRODUCT
Roche Molecular Biochemicals LightCycler 1.2 with software version 3.5. LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis
Recall Number Z-0487-2013
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
3,772 units
DISTRIBUTION
Nationwide
___________________________________
