BD antibiotic susceptibility test disc accuracy failures may affect H. influenzae diagnosis
Becton Dickinson is recalling antibiotic susceptibility test discs due to quality control failures that may produce inaccurate results. These failures could delay diagnosis and lead to inappropriate 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: This is an FDA Class II device recall with no reported illnesses or injuries. The recall addresses a risk-of-harm scenario where inaccurate diagnostic testing could lead to delayed diagnosis and inappropriate antibiotic selection. Per the severity rubric, recalls involving risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
BD BBL Sensi Disc Ciprofloxacin 5 ug test discs (Catalog Numbers 231657 and 231658) are being recalled by Becton Dickinson & Co. These discs are used in clinical laboratories for antibiotic susceptibility testing to determine the sensitivity of H. influenzae bacteria to antibiotics. Approximately 2.3 million units were distributed nationwide in the United States and internationally.
The FDA identified possible quality control and accuracy failures in these test discs. The failures may result in test discs that produce inaccurate or irreproducible results, potentially leading to product discard, delayed test results, or adverse diagnostic outcomes.
Inaccurate test results could cause delayed diagnosis of H. influenzae infections and inappropriate selection of antibiotics for treatment. Patients may receive incorrect antibiotics, potentially leading to extended or ineffective treatment.
Healthcare facilities and laboratories using these discs should review their inventory and contact Becton Dickinson & Co. for instructions on device replacement or proper disposal.
The recalled product
- Product
- BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657¿and 231658¿
- 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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