BioMérieux Software Update Recalled for Patient Information Mislabeling
BioMérieux is recalling 205 software update kits for clinical instruments 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. The hazard involves mislabeling of patient information, which is a significant quality issue but does not involve direct physical injury or high-risk pathogens, fitting the Moderate severity criteria for labeling errors.
Plain-English summary
BioMérieux Inc is recalling 205 kits of the bioMérieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411956. The recall is due to a software miscommunication that may cause the product to mislabel patient information on culture specimen bottles.
The affected software update is used for clinical instruments commonly utilized to isolate and recover specimens from adult and older pediatric patients who are acutely ill with signs and symptoms suggestive of bloodstream infection. The kits are identified by B.40 firmware.
The recall covers worldwide distribution, including the United States and numerous international locations. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411956 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric…
- 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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