BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMérieux is recalling 163 units of the 3D B.40 software update because a defect may cause patient information to be mislabeled on culture specimen bottles.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 is a labeling error (mislabeling patient information) without reported injuries or illnesses, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
BioMérieux Inc. is recalling 163 units of the 3D B.40 ZIP-ML05 clinical instrument software update, catalog number 412625. This software is used with clinical instruments to isolate and recover specimens from adult and older pediatric patients who are acutely ill with signs of bloodstream infection.
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. No specific instructions for consumers are provided in the source text, but the defect involves the accuracy of patient data on specimen bottles.
The recalled product
- Product
- bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412625 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and…
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 163
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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