BioMerieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMerieux is recalling 671 units of the 3D B.40 software update 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 involves a software miscommunication leading to potential mislabeling of patient information. This is a labeling error without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
BioMerieux Inc is recalling 671 units of the 3D B.40 ZIP-ML06 clinical instrument software update, catalog number 412626. The product is a software update for a clinical instrument used to isolate and recover specimens from patients with suspected bloodstream infections.
The recall was initiated because the product may mislabel patient information on culture specimen bottles due to a software miscommunication. This error could result in incorrect patient data being associated with the specimen.
The affected units were distributed worldwide, including in the United States and numerous international locations. The recall is identified by B.40 firmware. Consumers and healthcare facilities should contact BioMerieux Inc for further instructions on how to address the software issue.
The recalled product
- Product
- bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412626 Software update for the clinical instrument which is most commonly used to isolate and recover specimens…
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 671
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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