BioMerieux B.40 Dualt-ML Software Update Recalled for Mislabeling Risk
BioMerieux is recalling B.40 Dualt-ML software updates because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.
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 hazard involves a labeling error (mislabeling patient information) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
BioMerieux Inc is recalling the B.40 Dualt-ML Industry instrument software update, catalog number 412950. The product is a software update for an instrument commonly used to isolate and recover specimens from adult and older pediatric patients who are acutely ill with signs and symptoms suggestive of bloodstream infection.
The recall is being conducted because the product may mislabel patient information on culture specimen bottles due to a software miscommunication. The affected units are identified by B.40 firmware. The recall involves 12 kits.
The product was distributed worldwide, including in the United States and numerous international locations. Consumers and healthcare facilities should contact BioMerieux Inc for further instructions regarding the recall.
The recalled product
- Product
- bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument software update, English, Spanish, Italian, German, French, Japanese, Brazilian, Portuguese, catalog number 412950 Software update for an instrument which is most commonly used to isolate and recover…
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 12
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)
- Identified by B.40 firmware
Distribution
Part of a larger recall action
This product is one of 31 recalled by Biomerieux Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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