Company:Roche Molecular Systems, Inc
Date of Enforcement Report 10/21/2009
Class:ll

PRODUCT
AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001, catalog number 04807197001, catalog number 04862392001, catalog number 05093236001, and catalog number 05201357001. Automated sample preparation for nucleic acid analysis on either the COBAS TaqMan or COBAS TaqMan 48. COBAS AmpliPrep/COBAS TaqMan is capable of tuning HBV, HCV, and HIV tests. Recall # Z-1928-2009

REASON
Software bug: A unique series of events involving the COBAS AmpliPrep instrument running AMPLILINK software version 3.2.2 that results in specimens being amplified and detected with the wrong parameters. The error can occur on either COBAS AmpliPrep/COBAS TaqMan 48, COBAS AmpliPrep/COBAS TaqMan (docked) or cobas s 201 system (docked) running Amplilink Software versions 3.1 or 3.2 series up to and including 3.2.2.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Molecular Systems, Inc., Somerville, NJ, by letters on June 2, 2009.
Manufacturer: Roche Instrument Center AG, Rotkreuz, Switzerland. Firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
282 units

DISTRIBUTION
Nationwide