Device product
cobas Liat Analyzer, for in vitro diagnostic use.
Z-2543-2015
Product summary
- Event
- Event 71785
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 pieces
- Official record key
device-enforcement:Z-2543-2015
Official wording
Reason: 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.
Code information: Production Identifier (Lot/Serial Number): M1-E-00375, M1-E-00380, M1-E-00381, M1-E-00382, M1-E-00389
Distribution pattern: US Distribution to the states of :TX and NC.
Derived failure modes
-
Unknown
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.