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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- 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
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