BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMérieux is recalling 69 units of the 3D B.40 software update because a defect 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 score.
Plain-English summary
BioMérieux Inc. is recalling 69 kits of the 3D B.40 USB-ML06 clinical instrument software update, catalog number 412622. The recall is due to a software miscommunication that may result in the mislabeling of patient information on culture specimen bottles.
The affected software is used with clinical instruments commonly employed to isolate and recover specimens from adult and older pediatric patients who are acutely ill with signs and symptoms suggestive of bloodstream infection. The recall covers units distributed worldwide, including specific states in the United States and numerous international locations.
Healthcare facilities and consumers should stop using the affected software update and contact BioMérieux Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412622 Software update for the clinical instrument which is most commonly used to isolate and recover specimens draw
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 69
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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