Biomerieux Recalls Granada Biphasic Broth Due to Missing FDA Clearance
Biomerieux Inc is recalling 24 cartons of Granada Biphasic Broth because the product lacks required FDA 510(k) clearance for marketing in the United States.
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 driven by a regulatory compliance issue (missing 510(k) clearance) rather than a direct safety hazard or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomerieux Inc is recalling 24 cartons of Granada Biphasic Broth, a selective medium used for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens. The affected units are identified by REF 42722 and Lot Numbers 896, 897, and 899.
The recall was initiated because the U.S. Food and Drug Administration determined that the product requires 510(k) clearance to continue marketing and distribution in the United States. The product was distributed to the states of California, Georgia, Indiana, Massachusetts, Minnesota, Missouri, New York, Ohio, and Pennsylvania.
Healthcare facilities and consumers who possess this product should stop using it and contact Biomerieux Inc for further instructions.
The recalled product
- Product
- Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.
- Manufacturer
- Biomerieux Inc
- Affected units
- 24
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 (2)
- REF 42722 - Lot Numbers 896
- 897 & 899
Distribution
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