BD BBL Sensi Disc Ceftriaxone Test Discs Recalled for Susceptibility Testing Accuracy Issues
BD BBL Sensi Disc Ceftriaxone susceptibility test discs may have accuracy and quality control failures. These defects could lead to delayed diagnosis or incorrect antibiotic selection for H. influenzae infections.
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 diagnostic error affecting treatment decisions. The recall involves possible quality control and accuracy failures in susceptibility testing that could lead to incorrect antibiotic selection and delayed diagnosis, though no illnesses have been reported.
Plain-English summary
BD BBL Sensi Disc Ceftriaxone 30 ug susceptibility test discs are being recalled for possible accuracy and quality control failures. These laboratory discs are used to determine which antibiotics are effective against Haemophilus influenzae bacterial samples. The defects may cause inaccurate test results, product discard, or delayed results.
Inaccurate test results could lead clinical laboratories to select inappropriate antibiotics for treatment, delay diagnosis, or inadvertently extend antibiotic exposure and treatment duration. Approximately 2.3 million units have been distributed domestically and internationally, affecting Catalog Numbers 231634 and 231635 across multiple lot numbers.
Healthcare facilities and clinical laboratories should discontinue use of the affected lots immediately. Contact Becton Dickinson & Co. for guidance on product replacement, testing recommendations, or verification of previous results. If you have questions about your diagnosis or treatment, consult your healthcare provider.
The recalled product
- Product
- BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231634 and 231635¿
- 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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