FDA-Device2015-09-09Class II

cobas Liat Analyzer, for in vitro diagnostic use.

Roche Molecular Systems, Inc.
Hazard

Due to a supplier issue, the incorrect green and amber LED components were used in the manufacture of the LED printed circuit board assemblies (PCBA) in certain cobas Liat Analyzers.

Sold states
US Distribution to the states of :TX and NC.
Affected count
5 pieces
Manufactured in
1080 US Highway 202 S, N/A, Branchburg, NJ, United States
Products
cobas Liat Analyzer, for in vitro diagnostic use.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2543-2015

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