BioMerieux BacT/ALERT Combo Module Recalled for Software Miscommunication
BioMerieux is recalling 26 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, but the hazard is a software miscommunication leading to mislabeling, which is a minor labeling error without reported injuries, fitting the Moderate criteria.
Plain-English summary
BioMerieux Inc is recalling 26 units of the BacT/ALERT Combo Module, catalog number 200291. The product is an industrial instrument used to isolate and recover specimens from patients with signs of bloodstream infection. The recall is due to a software miscommunication that may cause the device to mislabel patient information on culture specimen bottles.
The affected modules are identified by B.40 firmware. The products were distributed worldwide, including to the United States and numerous international locations. The source text does not report any specific illnesses or injuries associated with this recall.
Healthcare facilities should contact BioMerieux Inc for instructions on how to handle the affected modules. Consumers are not typically the end-users of this specific industrial instrument, but any individual with questions regarding the recall should contact the manufacturer.
The recalled product
- Product
- bioMerieux BacT/ALERT Combo Module, catalog number 200291, 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
- 26
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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