Z-1014-2024 Class II Ongoing
FDA device recall Z-1014-2024 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 Augmentin - 3¿g, Catalog Number 291270¿used for semi-quantitative in vitro susceptibility testing.
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. 291270¿ UDI-DI N/A Lots 3030893 3093584 3184136 Product not distributed in the US
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1014-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026