BioMerieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMerieux is recalling 12 kits of 3D B.40 software updates 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 labeling error (mislabeling patient information) without reported illnesses or injuries, which aligns with the rubric for minor labeling errors or low-risk issues.
Plain-English summary
BioMerieux Inc is recalling 12 kits of the 3D B.40 USB-ML05 clinical instrument software update (catalog number 412621). The software update is used for a clinical instrument that isolates and recovers specimens from adult and older pediatric 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. The affected units are identified by B.40 firmware.
The product was distributed worldwide, including in the United States and numerous international countries. The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the recall.
The recalled product
- Product
- bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412621 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
- 12
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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