BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMérieux is recalling 250 units of the 3D B.40 software update 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 is classified as FDA Class II, and the hazard involves a labeling error (mislabeling patient information) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
BioMérieux Inc is recalling 250 kits of the 3D B.40 ZIP-ML03 clinical instrument software update. 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 issue could affect the accuracy of patient data associated with the specimens.
The affected software was distributed worldwide, including in the United States and numerous international locations. The product is identified by B.40 firmware. Consumers and healthcare facilities should contact BioMérieux Inc for further instructions on how to address the software issue.
The recalled product
- Product
- bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412623 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pe
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 250
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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