Antibiotic Susceptibility Test Discs Recalled for Accuracy and QC Failures
Becton Dickinson is recalling BD BBL Sensi Disc Minocycline test discs due to potential accuracy and quality control failures that may cause delayed test results, missed diagnoses, 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: This is an FDA Class II device with potential quality control and accuracy failures, classified as a risk-of-harm product. The source text does not report any illnesses or injuries, and the hazard is stated as potential rather than confirmed, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Becton Dickinson & Co. is recalling BD BBL Sensi Disc Minocycline (30 micrograms) test discs, catalog numbers 231250 and 231251. These laboratory test discs are used for semi-quantitative in vitro antibiotic susceptibility testing, particularly for Haemophilus influenzae. The recall affects 2,363,168 total units distributed domestically nationwide and internationally worldwide.
The FDA determined that these test discs may have reproducibility, accuracy, and/or quality control (QC) failures. These failures may cause product discard, delayed test results, or additional adverse diagnostic outcomes such as delayed diagnosis, selection of inappropriate antibiotics, or extended duration of antibiotic exposure and treatment.
The recalled product
- Product
- BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231250 and 231251¿
- 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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