BioMérieux BacT/ALERT 3D 60 Recalled for Software Mislabeling Error
BioMérieux is recalling 145 BacT/ALERT 3D 60 modules worldwide because a software error 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 causing mislabeling of patient information, which is a significant quality issue but does not involve a direct physical hazard like a broken part or toxic substance, fitting the Moderate criteria for labeling errors.
Plain-English summary
BioMérieux Inc is recalling 145 units of the BacT/ALERT 3D 60 clinical instrument, catalog number 248009. The recall is due to a software miscommunication that may cause the product to mislabel patient information on culture specimen bottles. The affected units are identified by B.40 firmware.
The BacT/ALERT 3D 60 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 covers units distributed worldwide, including in the United States and numerous international locations.
The source text does not specify instructions for consumers or healthcare providers regarding the recall action. No illnesses or injuries are reported in the provided text.
The recalled product
- Product
- bioMerieux BacT/ALERT 3D 60, catalog number, 248009, 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, which…
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 145
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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