BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMérieux is recalling 29 units of the 3D B.40 USB-ML03 software update due to a defect that may mislabel patient information 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 is classified as FDA Class II, and the hazard involves a labeling error that could lead to patient safety issues, fitting the criteria for a moderate severity recall.
Plain-English summary
BioMérieux Inc is recalling 29 units of the 3D B.40 USB-ML03 software update, catalog number 412559. This software is used with clinical instruments to isolate and recover specimens from patients with suspected bloodstream infections.
The recall was initiated because a software miscommunication may cause the product to mislabel patient information on culture specimen bottles. The affected units were distributed worldwide, including in the United States and numerous international locations.
Healthcare facilities should contact BioMérieux for instructions on how to manage the affected software updates.
The recalled product
- Product
- bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412559 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 29
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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