BioMérieux 3D IND Software Update Recalled for Patient Mislabeling
BioMérieux is recalling 20 kits of the 3D IND USB-ML 02 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 labeling error (mislabeling patient information) without reported injuries or illnesses, which aligns with the rubric criteria for minor labeling errors or low-risk contamination.
Plain-English summary
BioMérieux Inc is recalling 20 kits of the 3D IND USB-ML 02 software update, catalog number 412006. This software update is intended 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 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. The source text does not specify instructions for consumers or healthcare providers regarding the recall.
The recalled product
- Product
- bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument software update, English, Spanish, Italian, catalog number 412006 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
- 20
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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