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Recall Observatory FDA recall evidence

Device product

cobas Liat Analyzer, for in vitro diagnostic use.

Z-2543-2015

July 24, 2015

Class II

Product summary

Firm
Roche Molecular Systems, Inc.
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

    reason.no_named_rule · v1.0.0

    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.