Home / Recalls / Medical Devices
Roche Molecular Systems, Inc. recalls cobas¿ Liat¿ Analyzer
Recalled July 27, 2016 · FDA recall Z-2216-2016 · Roche Molecular Systems
Hazard
Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results. · FDA Class II
Units
2
Sold at
Distributed in NC and WA.
Description
Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.
Product
cobas¿ Liat¿ Analyzer
Manufacturer(s)
Roche Molecular Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →