Z-1012-2024 Class II Ongoing
FDA device recall Z-1012-2024 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 Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Catalog No. 231263. 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. 230705 UDI-DI 00382902307051 Lots 1301474 1334111 2025840 2146318 2242344 2276051 2333100 3150355 3234179 ; Catalog No. 231264¿ UDI-DI 30382902312643 Lots 2333100 3030225 3058510 3150355 3234179 3282314 1301474 1334111 2003260 2025840 2146318 2242344 2276051; Catalog No. 231263 UDI-DI 30382902312636 Lots 3010977 3058508 3184064 3234190 1302042 2003517 2146414 2243865 2277199 2339360
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1012-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026