BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMérieux is recalling 860 units of 3D B.40 software updates 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 (mislabeling patient information) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
BioMérieux Inc is recalling 860 units of the 3D B.40 ZIP-ML 02 clinical instrument software update (catalog number 411815). The recall was initiated because the software may mislabel patient information on culture specimen bottles due to a software miscommunication. This software is used with clinical instruments commonly employed to isolate and recover specimens from adult and older pediatric patients with suspected bloodstream infections.
The affected software was distributed worldwide, including in the United States and numerous international locations. The specific units are identified by the B.40 firmware. The source text does not specify the exact number of patients affected or report any specific adverse health events resulting from the mislabeling.
Healthcare facilities and consumers who have this specific software update should contact BioMérieux Inc for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02, Clinical instrument software, English, Spanish, Italian, catalog number 411815 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
- 860
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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