Roche Molecular Systems, Inc. recalls Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep ins

Recalled December 19, 2012 · FDA recall Z-0484-2013 · Roche Molecular Systems

Hazard

Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. · FDA Class II

Units

884 units

Sold at

Nationwide Distribution

Description

Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.

Product

Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLICOR¿ analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain Reaction) molecular diagnostic analytes.

Manufacturer(s)

Roche Molecular Systems, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →