BD BACTEC Plus Aerobic/F Culture Vials (Plastic)
by Becton, Dickinson and Company EUDAMED510(k)
Active Open recall
510(k) K113558
Regulatory status
Recall ongoing. 1 ongoing FDA recall names this device. See recalls
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK113558 | Date16 Mar 2012 | StatusActive |
| European Union | CE/IVDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Recalls
-
- Ongoing Z-0110-2024
Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode sequence numbers have been identified on more than one vial.
Specification
- 510(k) Number
- FDA Product Code
- MDB
- Device Class
- Class I
- Regulation
- 21 CFR Part 866.2560
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The BD BACTEC Plus Aerobic/F Culture Vials (Plastic) are a type of blood culturing system designed for the aerobic culture and recovery of bacteria and yeast from blood samples. These vials contain an enriched soybean-casein digest broth medium with antibiotic-neutralizing resins, enabling effective isolation of microorganisms in the presence of antimicrobial agents.
These single-use, sterile plastic vials are intended for use in microbiology laboratories to culture aerobic organisms from 3–10 mL blood samples. Supplied as part of the BD BACTEC Plus system, they comply with FDA 510(k) clearance and IVDR requirements. Storage and handling follow standard aseptic protocols for blood culture media, and their use is governed by regulatory classifications under device code MDB and regulation number 866.2560.
From the manufacturer
BD BACTEC ™ Plus Aerobic/F culture vials Contains antibiotic-absorbing resin media that effectively neutralizes 14 classes of antibiotics, 10 classes of anti-cancer drugs and 4 classes of anti-fungal agents. Suitable for aerobic culture and recovery of bacteria and yeast from blood.
Overview BD BACTEC™ Plus Aerobic medium is an all-purpose, enriched soybean-casein digest broth medium capable of supporting the growth of aerobic organisms. This medium contains resins for antibiotic neutralization.
Other devices from Becton, Dickinson and Company
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the BD BACTEC Plus Aerobic/F Culture Vials (plastic) in a clinical setting?
These vials are designed specifically for the aerobic culture and recovery of bacteria and yeast from blood samples. The enriched soybean-casein digest broth medium, combined with antibiotic-neutralizing resins, helps isolate microorganisms even when antimicrobial agents are present in the sample, ensuring reliable detection of pathogens in microbiology labs.
How are these culture vials supplied, and what type of blood sample volume do they accommodate?
The vials are supplied as single-use, sterile plastic components of the BD BACTEC Plus system. Each vial is intended for culturing aerobic organisms from blood samples ranging between 3–10 milliliters, making them versatile for standard blood culture procedures.
Are these vials reusable, and what storage or handling precautions should be taken?
No, these vials are single-use only and must be discarded after one use to maintain sterility and prevent contamination. Storage and handling follow standard aseptic protocols for blood culture media, as they are sterile products intended for microbiological use in controlled laboratory environments.
What regulatory pathways have these vials undergone, and how does that affect their use?
The BD BACTEC Plus Aerobic/F Culture Vials (plastic) have undergone FDA 510(k) clearance and comply with In Vitro Diagnostic Regulation (IVDR) requirements. This means they meet U.S. and EU regulatory standards for blood culture media, ensuring their safety, performance, and suitability for clinical microbiology applications as intended.
What types of microorganisms can these vials effectively culture, and why is the medium formulation important?
These vials are optimized for culturing aerobic bacteria and yeast from blood samples. The medium’s formulation—soybean-casein digest broth with antibiotic-neutralizing resins—helps neutralize antimicrobial agents that might otherwise inhibit microbial growth, improving the likelihood of detecting pathogens like *Staphylococcus*, *Escherichia coli*, or fungal species in clinical specimens.