The Recall Desk
ModerateFDA (Devices)·Z-2543-2015·Announced 2015-09-09

Roche Recalls cobas Liat Analyzers Due to Incorrect LED Components

Roche Molecular Systems is recalling five cobas Liat Analyzers because incorrect LED components were used in the printed circuit board assemblies.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or specific functional failures, fitting the criteria for a moderate severity recall.

Plain-English summary

Roche Molecular Systems, Inc. is recalling five units of the cobas Liat Analyzer, a device used for in vitro diagnostic purposes. The recall was initiated due to a supplier issue that resulted in the use of incorrect green and amber LED components in the manufacture of the LED printed circuit board assemblies (PCBA).

The affected units are identified by the following production identifiers: M1-E-00375, M1-E-00380, M1-E-00381, M1-E-00382, and M1-E-00389. These devices were distributed in the United States to the states of Texas and North Carolina.

The source text does not specify specific actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with the defect.

The recalled product

Product
cobas Liat Analyzer, for in vitro diagnostic use.
Manufacturer
Roche Molecular Systems, Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
5

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Production Identifier (Lot/Serial Number): M1-E-00375
  • M1-E-00380
  • M1-E-00381
  • M1-E-00382
  • M1-E-00389

Distribution

Distributed in 2 states:

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