Biomerieux BacT/ALERT Combo Module Recalled for Software Mislabeling
Biomerieux is recalling BacT/ALERT Combo Modules due to a software issue 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 is a software miscommunication leading to mislabeling. No illnesses or injuries are reported, fitting the criteria for a moderate severity recall involving labeling errors.
Plain-English summary
Biomerieux Inc is recalling the BacT/ALERT Combo Module, catalog number 247014, identified by B.40 firmware. The product is an industrial instrument used to isolate and recover specimens from patients with suspected bloodstream infections.
The recall is due to a software miscommunication that may cause the product to mislabel patient information on culture specimen bottles. The source text does not report any specific illnesses or injuries associated with this defect.
The affected modules were distributed worldwide, including in the United States and numerous international locations. Users should contact Biomerieux Inc for further instructions on how to address the software issue.
The recalled product
- Product
- bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection…
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 2
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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