BD BBL Sensi Disc Cefixime Antibiotic Susceptibility Test Accuracy Failures
BD BBL Sensi Disc Cefixime testing discs are recalled due to potential accuracy and quality control failures that may result in delayed diagnosis or inappropriate antibiotic selection in clinical laboratories.
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 a risk-of-harm diagnostic device where potential injury (diagnostic errors leading to delayed treatment or inappropriate antibiotic selection) has not yet been reported. The FDA Class II classification and theoretical hazard per the source text support a Score 3 per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
BD BBL Sensi Disc Cefixime - 5 μg discs (Catalog No. 231664) are being recalled due to potential reproducibility, accuracy, and quality control failures in antibiotic susceptibility testing for H. influenzae. These discs are used in clinical laboratories for semi-quantitative in vitro testing of bacterial susceptibility to cefixime.
Approximately 2,363,168 units were distributed nationwide in the United States and internationally worldwide. Affected lots are: 2004492, 3010077, 3223406, 1305984, and 2091014.
The accuracy failures may cause product discard, delayed test results, or diagnostic errors. Specifically, inaccurate test results could delay diagnosis, lead to selection of inappropriate antibiotics, or result in extended duration of antibiotic exposure and treatment.
Clinical laboratories should discontinue use of affected lots and contact Becton Dickinson & Co. for replacement products. Healthcare providers should review any antibiotic selections made based on tests conducted with affected discs.
The recalled product
- Product
- BD BBL Sensi Disc Cefixime - 5 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231664¿
- 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 · test accuracy failure
See all →- HighBD BBL Sensi Disc Doripenem antibiotic susceptibility testing accuracy failures
FDA (Devices) · 2024-02-14
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
- SevereRemel Recalls Gentamicin Antimicrobial Susceptibility Testing Discs
FDA (Devices) · 2015-12-23
- HighLevofloxacin Antimicrobial Susceptibility Discs Recalled Due to Packaging Mislabeling
FDA (Devices) · 2025-02-12
- ModerateRemel Recalls Oxoid Cefpodoxime Antimicrobial Susceptibility Test Discs
FDA (Devices) · 2014-01-29
- HighBD Posiflush Pre-Filled Normal Saline Syringes Recalled Due to Labeling Mix-up
FDA (Devices) · 2019-11-27