BioMerieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMerieux is recalling a software update for the 3D B.40 clinical instrument because it may mislabel patient information 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 a software update for the 3D B.40 clinical instrument, catalog number 412624. The product is a clinical instrument software update used to isolate and recover specimens from adult and older pediatric patients with signs of bloodstream infection.
The recall was initiated because the product may mislabel patient information on culture specimen bottles due to a software miscommunication. This defect could lead to incorrect patient data being associated with clinical specimens.
The affected software was distributed worldwide, including in the United States and numerous international locations. Users of the 3D B.40 instrument should contact BioMerieux Inc for further instructions regarding the software update.
The recalled product
- Product
- bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412624 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and…
- Manufacturer
- Biomerieux Inc
- Hazard
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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