Roche Molecular Systems, Inc. recalls cobas Liat Analyzer, for in vitro diagnostic use.
- Recall date
- July 24, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2543-2015
- FDA classification
- Class II
- Brand / firm
- Roche Molecular Systems, Inc.
- Sold / distributed
- US Distribution to the states of :TX and NC.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
cobas Liat Analyzer, for in vitro diagnostic use.
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