BD BBL Sensi Disc Ampicillin testing discs recalled for accuracy failures
Becton Dickinson is recalling 2.3 million antibiotic susceptibility testing discs due to accuracy and quality control failures. The discs may cause delayed or incorrect test results, potentially leading to inappropriate antibiotic selection.
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 medical device recall with no reported illnesses or injuries. The risk involves diagnostic failures in antibiotic susceptibility testing that could lead to delayed diagnosis or inappropriate antibiotic selection, representing a risk-of-harm scenario where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Co. is recalling BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 μg (Catalog No. 231660), a medical device used for in vitro antibiotic susceptibility testing. Over 2.3 million units have been distributed nationwide in the United States and internationally.
The FDA has determined there is a possibility of reproducibility, accuracy, and quality control failures when these discs are used for susceptibility testing of H. influenzae. This may result in inaccurate test results, product discard, or delayed test outcomes.
Potential adverse outcomes from inaccurate test results include delayed diagnosis, selection of inappropriate antibiotics, or extended duration of antibiotic exposure and treatment. The affected product lots are: 3010074, 3093387, 3163062, 3223403, 3234193, 2063349, 2119619, and 2276123.
The recalled product
- Product
- BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 ¿g, Catalog Number 231660. Used for semi-quantitative in vitro susceptibility testing.
- Manufacturer
- Becton Dickinson & Co.
- 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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