BioMerieux Recalls NucliSENS Lysis Buffer Due to Colored Eluates
BioMerieux SA is recalling NucliSENS Lysis Buffer because colored eluates were observed during whole blood extractions.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a quality defect (colored eluates) without confirmed adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
BioMerieux SA is recalling 1,025 units of NucliSENS Lysis Buffer, REF 200292, Lot Number 16092902. The product is intended for the release of total nucleic acid from biological specimens.
The recall was initiated due to a problem with colored eluates observed during whole blood extractions. The affected units were distributed worldwide, including in the United States (Illinois, Ohio, and Washington) and internationally to Argentina, Australia, Brazil, Chile, Colombia, France, Hong Kong, Italy, the Netherlands, Peru, Spain, Uganda, the United Kingdom, and Zimbabwe.
Users of this product should stop using the affected lots and contact BioMerieux SA for further instructions or a replacement.
The recalled product
- Product
- NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological specimens
- Manufacturer
- BioMerieux SA
- Hazard
- Affected units
- 1,025
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 (1)
- Lot Number 16092902
Distribution
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