bioMerieux Recalls BacT/ALERT SA Blood Culture Bottles with Uncured Sensors
bioMerieux, Inc. is recalling BacT/ALERT SA Blood Culture Bottles because some units may contain uncured sensors, potentially affecting the detection of microorganisms.
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 source text does not report any hospitalizations, injuries, or illnesses. The hazard is a functional defect (uncured sensors) that may affect test accuracy, fitting the criteria for a moderate severity recall involving a risk-of-harm product where injury has not yet been reported.
Plain-English summary
bioMerieux, Inc. is recalling 1,690 cases of BacT/ALERT SA Blood Culture Bottles, Catalog Number 259789, Lot 1031866. The recall was initiated because the bottles may contain uncured sensors. The BacT/ALERT SA reagent bottle is intended to recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
The affected product was distributed worldwide, including in the United States (specifically AR, AZ, CA, CO, DE, FL, GA, IL, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WI, and WV) and in China, Curacao, and Japan. The source text does not report any illnesses or injuries associated with this recall.
Healthcare facilities and consumers should check their inventory for BacT/ALERT SA Blood Culture Bottles with Catalog Number 259789 and Lot 1031866. If found, these units should be removed from use and returned to the manufacturer or disposed of according to local regulations. The source text does not provide specific instructions for return or disposal beyond the standard recall procedure.
The recalled product
- Product
- BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
- Manufacturer
- bioMerieux, Inc.
- Affected units
- 1,690
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 (2)
- Catalog Number: 259789
- Lots/Batch: 1031866
Distribution
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