BioMérieux 3D B.40 Software Update Recalled for Patient Mislabeling
BioMérieux is recalling 30 units of the 3D B.40 software update 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 is classified as FDA Class II, and the hazard involves a labeling error that could lead to patient safety issues, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
BioMérieux Inc is recalling 30 kits of the 3D B.40 BTA3D-ZH01 clinical instrument software update, catalog number 411816. 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 in the United States and numerous international locations.
Healthcare facilities should contact BioMérieux Inc for instructions on how to manage the affected software and ensure accurate patient labeling.
The recalled product
- Product
- bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument software, Chinese, catalog number 411816 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that ar
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 30
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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