Recall archive / FDA device enforcement
BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibilit... — FDA record Z-1039-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 8, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231536 and 231539¿
- Reason
- There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
- Classification
- Class II
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- 2,363,168 total units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1039-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Catalog No. 231536 UDI-DI 00382902315360 Lots 1060689 1116935 1210905 1242939 1306103 1334461 2004540 2025116 2056456 2108378 2146453 2301307 3003869 3062089 3094151 3118079 3152968 3248444 0309595 0343394; Catalog No. 231539¿ UDI-DI 30382902315392 Lots 2339393 3003869 3062089 3094151 3118079 3152968 3214768 3248444 3282335 0309595 0343394 1060689 1116935 1148543 1210905 1242939 1306103 1334461 2004540 2025116 2056456 2108378 2146453 2277321 2301307 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic distribution nationwide. International distribution worldwide.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 14, 2024
- Recall initiation date
- Jan 8, 2024
- Center classification date
- Feb 8, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.