Cefotaxime antibiotic susceptibility test discs recalled for potential testing accuracy failures
BD BBL Sensi Disc Cefotaxime susceptibility testing discs may produce inaccurate results for H. influenzae, potentially leading to delayed diagnosis and inappropriate antibiotic selection. The FDA has recalled 2,363,168 units distributed domestically and internationally.
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: This is an FDA Class II medical device recall for a diagnostic test where accuracy and quality control failures could lead to delayed diagnosis, inappropriate antibiotic selection, and extended treatment. No illnesses or injuries are reported in the source, supporting classification as a risk-of-harm product with a High (3) severity level.
Plain-English summary
BD BBL Sensi Disc Cefotaxime is a laboratory testing disc used for in vitro antibiotic susceptibility testing. Manufactured by Becton Dickinson & Co., the product (catalog numbers 231606, 231607, and 291308) has been recalled due to possible accuracy and quality control failures that may affect test reproducibility.
A total of 2,363,168 units have been distributed domestically and internationally. These failures in the susceptibility testing discs may result in inaccurate results when testing H. influenzae, potentially leading to delayed diagnosis, selection of inappropriate antibiotics, or extended duration of antibiotic therapy. Laboratories may also experience product discard or delayed test results.
The recalled product
- Product
- BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607¿; 5 ug, Catalog No. 291308¿
- 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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