Antibiotic susceptibility test discs recalled for accuracy and quality failures
Becton Dickinson is recalling BD BBL Sensi Disc Azithromycin test discs due to potential accuracy and quality control failures that may delay diagnosis or result in 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 recall involving a diagnostic device with potential for serious patient harm through delayed diagnosis or inappropriate treatment decisions, but with no reported illnesses or injuries. Fits the rubric criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
BD BBL Sensi Disc Azithromycin -15 μg (Catalog Number 231682) is a laboratory test disc used to determine if bacteria are resistant to the antibiotic azithromycin. Becton Dickinson & Co. is recalling approximately 2.3 million units distributed throughout the United States and internationally.
The test discs may not work correctly when testing H. influenzae bacteria. Specifically, they may have accuracy and quality control problems that could cause the laboratory test to fail.
If the test fails, the laboratory may get wrong results or experience delays, which could lead to a patient being prescribed the wrong antibiotic or having their diagnosis delayed. The affected products may also need to be discarded.
Laboratories and healthcare facilities that received the affected lots (3093408, 3163065, 2004501, 2147712, 2304517) should stop using them and contact Becton Dickinson for replacement or further guidance.
The recalled product
- Product
- BD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682¿used for semi-quantitative in vitro susceptibility testing.
- 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.
See all 30 products in this recall →Related recalls
Same manufacturer · Becton Dickinson & Co.
See all →- SevereBD Phoenix Panel NMIC-306 Recalled for Quality Control Failures
FDA (Devices) · 2026-10-21
- HighBD Phoenix Panel NMIC-312 recalled for classification error
FDA (Devices) · 2026-10-21
- ModerateBD GasPak EZ CO2 Pouch System gas generating sachets underperforming
FDA (Devices) · 2026-05-06
- ModerateBD GasPak EZ Campy Pouch System Recall for Below-Specification Gas Production
FDA (Devices) · 2026-05-06
- ModerateLaboratory cuvette arrays recalled over barcodes the analyser cannot read
FDA (Devices) · 2025-11-19
Same hazard · diagnostic error
See all →- ModeratePhilips Ingenia MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- HighSiemens Immulite 2000 Syphilis Screen Recall for Negative Bias
FDA (Devices) · 2026-08-26
- HighSiemens Immulite 2000 Syphilis Screen Recalled for Negative Bias
FDA (Devices) · 2026-08-26
- HighPhilips CT Scanners Recalled Due to Bolus Tracking Trigger Issue
FDA (Devices) · 2026-08-05
- HighPhilips IQon Spectral CT Recalled Due to Automatic Scan Trigger Failure
FDA (Devices) · 2026-08-05
Similar recalls
- HighBD Bacterial Susceptibility Test Discs Recall for Decreased Potency
FDA (Devices) · 2024-12-11
- HighBD Phoenix PMIC-108 Panels Recalled for False Susceptibility Test Results
FDA (Devices) · 2012-12-26
- HighBD Phoenix PMIC-107 Panels Recalled Due to Quality Control Failures
FDA (Devices) · 2017-12-06
- HighBecton Dickinson Recalls Vancomycin Screen Agar Due to Reduced Antimicrobial Levels
FDA (Devices) · 2013-07-31
- HighBD Phoenix PMIC-109 Recalled for False SXT Resistance Results
FDA (Devices) · 2021-01-06
- ModerateBD Affirm VPIII Microbial Identification Tests Recalled for Invalid Control Results
FDA (Devices) · 2013-08-07