BD Antibiotic Testing Discs Recalled for Accuracy Failures
Becton Dickinson recalled BD BBL Sensi Disc Augmentin testing discs due to potential accuracy and quality control failures in antibiotic susceptibility testing. Failures may lead to delayed diagnosis or 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: This is a Class II medical device recall involving potential failures in antibiotic susceptibility testing for H. influenzae. While no illnesses or injuries have been reported, the device failure could result in delayed diagnosis or inappropriate antibiotic selection, meeting the criterion for High severity as a risk-of-harm product with potential patient injury.
Plain-English summary
Becton Dickinson & Co. has recalled over 2.3 million units of BD BBL Sensi Disc Augmentin (Catalog No. 291270), a medical device used for antibiotic susceptibility testing. The recall affects lot numbers 3030893, 3093584, and 3184136.
The FDA classified this as a Class II recall due to the possibility of reproducibility, accuracy, and quality control failures in antibiotic susceptibility testing for H. influenzae. These test failures could result in inaccurate results that cause delayed diagnosis or inappropriate antibiotic selection.
Laboratories and healthcare facilities using these testing discs should identify and review any affected lot numbers in their inventory and verify the accuracy of results from the recalled product.
If you have access to the affected product, contact Becton Dickinson & Co. for instructions regarding corrective actions or product return.
The recalled product
- Product
- BD BBL Sensi Disc Augmentin - 3¿g, Catalog Number 291270¿used for semi-quantitative in vitro susceptibility testing.
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- accuracy-failure
- diagnostic-error
- qc-failure
Distribution
Distributed nationwide across the United States.
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