BD BBL Sensi Disc Antibiotic Test Discs Recalled for Accuracy Failures
Becton Dickinson is recalling BD BBL Sensi Disc antibiotic susceptibility test discs due to potential accuracy and quality control failures that may lead to incorrect antibiotic selection and delayed diagnosis.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with potential for serious diagnostic harm including delayed diagnosis and inappropriate antibiotic selection, but no reported illnesses or injuries. Qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Co. is recalling specific lots of BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim discs, which are used for semi-quantitative in vitro antibiotic susceptibility testing. The company identified a possibility of reproducibility, accuracy, and quality control failures that specifically affect H. influenzae testing.
Approximately 2,363,168 units have been distributed domestically and internationally. Affected products include Catalog Nos. 231536 and 231539, with specific lot numbers detailed in the recall notice.
The potential failures may result in product discard or delayed test results, leading to adverse diagnostic outcomes. These may include delayed diagnosis, selection of inappropriate antibiotics, or extended duration of antibiotic exposure and treatment.
The recalled product
- Product
- BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231536 and 231539¿
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 2,363,168
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 recalled by Becton Dickinson & Co. 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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