BD BBL Sensi Disc Levofloxacin Testing Discs Recalled for Accuracy Failures
Becton Dickinson is recalling 2,363,168 units of BD BBL Sensi Disc Levofloxacin testing discs (Catalog No. 231705, 231706) due to potential accuracy and quality control failures in antibiotic susceptibility testing that could lead to delayed diagnosis 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 FDA Class II recall involves laboratory testing equipment with potential for serious diagnostic errors—delayed diagnosis and inappropriate antibiotic selection—but no reported illnesses or injuries. Per the severity rubric, this qualifies as High: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Becton Dickinson & Co. is recalling BD BBL Sensi Disc Levofloxacin-5 ug (Catalog Numbers 231705 and 231706), laboratory testing discs used for antibiotic susceptibility testing of Haemophilus influenzae. A total of 2,363,168 units were distributed domestically and internationally.
The recall is due to a possibility of reproducibility, accuracy, and quality control failures in the susceptibility testing process. These failures may result in incorrect test results, leading to delayed diagnoses, product discard, additional testing, inappropriate antibiotic selection, or extended antibiotic exposure in patient care.
Specific lot numbers for both catalog numbers are identified in this recall notice. Customers may identify affected products using the UDI-DI and lot numbers provided.
The recalled product
- Product
- BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705 and 231706¿
- 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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