Z-1023-2024 Class II Ongoing
FDA device recall Z-1023-2024 was initiated by Becton Dickinson & Co. on Jan 8, 2024 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 2,363,168 total units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 14, 2024
- Initiation Date
- Jan 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,363,168 total units
Product Description
BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231632¿and 231633¿
Reason for Recall
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.
Distribution Pattern
Domestic distribution nationwide. International distribution worldwide.
Code Information
Catalog No. 231632¿ UDI-DI 00382902316329 Lots 2004587 2028883 2119589 2146527 2242568 2301371 3118111 3181037; Catalog No. 231633¿ UDI-DI 30382902316337 Lots 2242568 2301371 3062286 3118111 3181037 3223389 3290192 2004587 2028232 2028883 2028894 2056528 2119589 2146527
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1023-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026