BD BBL Moxifloxacin Test Discs Recalled for Susceptibility Testing Inaccuracy
BD BBL Sensi Disc Moxifloxacin test discs are recalled due to possible failures in antibiotic susceptibility testing accuracy. Test failures could lead to delayed diagnosis or 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 recall with no reported illnesses or injuries. As a risk-of-harm product where injury has not yet been reported, it meets the criterion for High severity per the rubric.
Plain-English summary
BD BBL Sensi Disc Moxifloxacin-5 ug is a laboratory diagnostic test disc used for antibiotic susceptibility testing of H. influenzae. Becton Dickinson & Co. has recalled 2,363,168 units distributed domestically nationwide and internationally.
The recall addresses a possibility of reproducibility, accuracy, and quality control failures in the antibiotic susceptibility testing process. Test failures could result in product discard, delayed test results, or adverse diagnostic outcomes including delayed diagnosis, inappropriate antibiotic selection, or extended antibiotic treatment duration.
The recalled product
- Product
- BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758¿
- 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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