BioMerieux B.40 Software Update Recalled for Patient Mislabeling
BioMerieux is recalling 23 B.40 software update kits because a software miscommunication may cause patient information to be mislabeled on culture specimen bottles.
What this means for you
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 defect causing mislabeling of patient information, which is a labeling error without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
BioMerieux Inc is recalling 23 kits of the B.40, 3D I USB-ML01 industry instrument software update (catalog number 413481). The recall is due to a software miscommunication that may cause patient information to be mislabeled on culture specimen bottles.
The affected software is used with instruments 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 products were distributed worldwide, including in the United States and numerous international locations.
Healthcare facilities should contact BioMerieux Inc for instructions on how to handle the recalled software update kits.
The recalled product
- Product
- bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413481 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric p
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 23
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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