BioMerieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMerieux is recalling 1,336 units of 3D B.40 software 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. The hazard involves a labeling error that could lead to clinical confusion, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
BioMerieux Inc is recalling 1,336 units of the 3D B.40 ZIP-ML01 clinical instrument software update (catalog number 411814). The software is used with clinical instruments to isolate and recover specimens from adult and older pediatric 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 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 on how to handle the recalled software.
The recalled product
- Product
- bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411814 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 1,336
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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