BioMérieux BTA3D Control Software Recall for Patient Mislabeling
BioMérieux is recalling BTA3D Control software due to a defect that may mislabel patient information 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 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 250 kits of the BTA3D Control-B-B.40 clinical instrument software, catalog number 411958. The product is a software update and USB mounting hardware used for clinical instruments that isolate and recover specimens from patients with suspected bloodstream infections.
The recall was initiated because the product may mislabel patient information on culture specimen bottles due to a software miscommunication. This defect could lead to incorrect patient data being associated with clinical specimens.
The affected software, identified by B.40 firmware, was distributed worldwide, including in the United States and numerous international locations. Consumers and healthcare facilities should contact BioMérieux Inc for further instructions on how to address the software defect.
The recalled product
- Product
- bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411958 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older…
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 250
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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