BD BBL Antibiotic Susceptibility Test Discs Recalled for Accuracy Failures
BD BBL Ceftazidime Sensi Discs used for antibiotic susceptibility testing may have accuracy failures affecting H. influenzae testing. This could lead to delayed 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: FDA Class II medical device with potential for serious patient harm through diagnostic delays and inappropriate antibiotic selection, but no reported illnesses or injuries. The hazard is testing failure affecting clinical decision-making for H. influenzae infections.
Plain-English summary
BD BBL Sensi Disc Ceftazidime 30 micrograms is used for in vitro antibiotic susceptibility testing in clinical laboratories. Becton Dickinson & Co. is recalling approximately 2.36 million units due to possible reproducibility, accuracy, and quality control failures that may affect testing results for Haemophilus influenzae. The recall affects Catalog Numbers 231632 and 231633.
These testing discs help laboratories determine which antibiotics are effective against H. influenzae infections. Quality control failures could result in inaccurate test results, delayed diagnostic outcomes, product discard, or failed testing procedures. Potential clinical consequences include delays in diagnosis, selection of inappropriate antibiotics for treatment, or extended duration of antibiotic therapy.
Affected units were distributed nationwide in the United States and internationally. Healthcare facilities and clinical laboratories using these discs should discontinue use of affected lots and contact their BD representative for replacement product or instructions.
The recalled product
- Product
- BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231632¿and 231633¿
- 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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