BD Sensi Disc Cefepime antibiotic susceptibility testing accuracy failures
Becton Dickinson is recalling BD BBL Sensi Disc Cefepime antibiotic testing discs due to accuracy and reproducibility failures. These laboratory products may produce inaccurate test results, potentially leading to delayed diagnoses or inappropriate antibiotic treatment.
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 significant diagnostic error and inappropriate treatment. No illnesses or actual harm have been reported; the hazard is theoretical, fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Becton Dickinson & Co. is recalling BD BBL Sensi Disc Cefepime (Catalog No. 231696), used in laboratory antibiotic susceptibility testing. The recall affects 2,363,168 total units distributed domestically nationwide and internationally. Affected lot numbers include 2339439, 3118297, 3163524, 3223410, 3243084, 3282873, 2063393, 2119624, 2119625, 2119626, 2147720, 2213567, and 2273732.
The discs may exhibit reproducibility, accuracy, and quality control failures when testing H. influenzae susceptibility to cefepime. This could result in product discard, delayed test results, or other diagnostic complications.
Potential consequences include delay in diagnosis, inappropriate antibiotic selection, or extended antibiotic treatment duration. Laboratories should identify affected lot numbers in their inventory and contact Becton Dickinson for guidance on recall procedures.
The recalled product
- Product
- BD BBL Sensi Disc Cefepime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231696¿
- 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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