Antibiotic susceptibility test discs recalled for accuracy and quality failures
Becton Dickinson is recalling BD BBL Sensi Disc Azithromycin test discs due to potential accuracy and quality control failures that may delay diagnosis or result in 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 recall involving a diagnostic device with potential for serious patient harm through delayed diagnosis or inappropriate treatment decisions, but with no reported illnesses or injuries. Fits the rubric criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
BD BBL Sensi Disc Azithromycin -15 μg (Catalog Number 231682) is a laboratory test disc used to determine if bacteria are resistant to the antibiotic azithromycin. Becton Dickinson & Co. is recalling approximately 2.3 million units distributed throughout the United States and internationally.
The test discs may not work correctly when testing H. influenzae bacteria. Specifically, they may have accuracy and quality control problems that could cause the laboratory test to fail.
If the test fails, the laboratory may get wrong results or experience delays, which could lead to a patient being prescribed the wrong antibiotic or having their diagnosis delayed. The affected products may also need to be discarded.
Laboratories and healthcare facilities that received the affected lots (3093408, 3163065, 2004501, 2147712, 2304517) should stop using them and contact Becton Dickinson for replacement or further guidance.
The recalled product
- Product
- BD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682¿used for semi-quantitative in vitro susceptibility testing.
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- diagnostic-error
- testing-inaccuracy
- qc-failure
Distribution
Distributed nationwide across the United States.
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