BioMerieux B.40 Software Update Recalled for Patient Mislabeling
BioMerieux is recalling B.40 software updates because a defect 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 that could lead to patient misidentification, which fits the criteria for moderate severity without reported injuries.
Plain-English summary
BioMerieux Inc is recalling 83 kits of the B.40 software update (catalog number 412002) due to a software miscommunication. This update is intended for instruments used to isolate and recover specimens from patients with suspected bloodstream infections.
The recall was initiated because the software defect may cause patient information to be mislabeled on culture specimen bottles. This error could lead to incorrect identification of patient samples.
The affected products were distributed worldwide, including in the United States and numerous international locations. Users of the B.40 instrument should contact BioMerieux for further instructions on how to proceed.
The recalled product
- Product
- bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 412002 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older…
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 83
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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