BioMerieux BTA3D Combo Software Recall for Patient Mislabeling
BioMerieux is recalling 205 BTA3D Combo software kits worldwide 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 recall.
Plain-English summary
BioMerieux Inc is recalling 205 kits of the BTA3D COMBO-B-B.40 clinical instrument software, catalog number 411957. The recall is due to a software miscommunication that may cause the product to mislabel patient information on culture specimen bottles.
The affected software is used for clinical instruments that isolate and recover specimens from adult and older pediatric patients with signs of bloodstream infection. The recall covers units distributed worldwide, including the United States and numerous international locations.
No specific instructions for consumers are provided in the source text, as the product is a clinical instrument software update. Healthcare facilities should verify their software version and contact the manufacturer for further guidance.
The recalled product
- Product
- bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411957 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediat
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 205
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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