Biomerieux B.40 Software Update Recalled for Patient Information Mislabeling
Biomerieux Inc is recalling 33 B.40 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, but the source text describes a labeling error (mislabeling patient information) without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Biomerieux Inc is recalling 33 units of the B.40, 3D I ZIP-ML01 software update (catalog number 413483). This software update is used for an instrument commonly employed 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 was initiated 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 product was distributed worldwide, including in the United States and numerous international locations.
Healthcare facilities and consumers who possess this specific software update should stop using it and contact Biomerieux Inc for further instructions on how to resolve the issue.
The recalled product
- Product
- bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413483 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric…
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 33
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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