BioMerieux BacT/ALERT Combo Modules Recalled for Software Mislabeling
BioMerieux is recalling 375 BacT/ALERT Combo Modules due to a software error 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 a software error leading to mislabeling, which is a significant quality issue but does not involve a direct physical hazard like fire or a high-risk pathogen. No injuries or illnesses are reported.
Plain-English summary
BioMerieux Inc is recalling 375 units of the BacT/ALERT Combo Module, catalog number 200290. This clinical instrument is 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 affected modules are identified by B.40 firmware. The products were distributed worldwide, including in the United States and numerous international locations. The source text does not specify the number of patients affected or report any illnesses or injuries resulting from the mislabeling.
Healthcare facilities should contact BioMerieux Inc for instructions on how to handle the recalled modules. Consumers are not directly affected as this is a clinical instrument used in medical settings.
The recalled product
- Product
- bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical 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
- 375
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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