Z-1030-2024 Class II Ongoing
FDA device recall Z-1030-2024 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 Ertapenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232174 and 232175¿
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. 232174 UDI-DI 00382902321743 Lots 1301766 1341479 2119610 2147329 2242618 2276113 2333166 3152004 3181140; Catalog No. 232175¿ UDI-DI 30382902321751 Lots 1301766 2276113 2333166 2333175 3152004 3181140 1341479 2119610 2119612 2147329 2242618
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1030-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026