bioMerieux BacT/ALERT Control Module Recalled for Patient Mislabeling
Biomerieux Inc is recalling 70 BacT/ALERT Control 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, which fits the criteria for moderate severity involving labeling errors without reported injuries.
Plain-English summary
Biomerieux Inc is recalling 70 units of the bioMerieux BacT/ALERT Control Module, catalog number 210147. This clinical instrument is used to isolate and recover specimens from adult and older pediatric patients who are acutely ill with signs and symptoms suggestive of bloodstream infection.
The recall was initiated because the product may mislabel patient information on culture specimen bottles due to a software miscommunication. The affected modules are identified by B.40 firmware.
The products were distributed worldwide, including in 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 used in healthcare settings.
The recalled product
- Product
- bioMerieux BacT/ALERT Control Module, catalog number 210147, 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
- 70
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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