Antibiotic susceptibility testing discs recalled for potential accuracy failures
Becton Dickinson's BD BBL Sensi Disc Cefuroxime testing discs may have accuracy, reproducibility, or quality-control failures in antibiotic susceptibility testing. This could delay diagnosis and lead to inappropriate antibiotic selection.
What this means for you
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 with potential for diagnostic failure (inaccurate antibiotic susceptibility testing), but no reported illnesses, injuries, or deaths. Classified as High per the rubric criterion for risk-of-harm products without confirmed injury.
Plain-English summary
Becton Dickinson & Co. is recalling 2,363,168 units of BD BBL Sensi Disc Cefuroxime (30 microgram discs, Catalog No. 231621), used in laboratory antibiotic susceptibility testing for Haemophilus influenzae. The affected lots are: 2304487, 3093372, 3158087, 3223379, 1335657, 2004439, 2090487, 2147701, and 2210631.
The product may have failures in reproducibility, accuracy, and quality-control performance. These failures could affect the reliability of test results used to determine which antibiotics are most effective against H. influenzae infections.
According to the FDA, these failures may cause product discard, delayed results, or additional adverse diagnostic outcomes, including delayed diagnosis, selection of inappropriate antibiotics, or extended duration of antibiotic exposure during treatment. The affected discs have been distributed nationwide domestically and worldwide internationally.
The recalled product
- Product
- BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231621¿
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- testing-accuracy-failure
- antibiotic-selection-error
- diagnostic-delay
Distribution
Distributed nationwide across the United States.
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