BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermentation, oxidation, degradation, and hydrolysis in combination with chromogenic and fluorogenic substrates along with carbon sources for bacterial identification and quantitation.
Enforcement
- Recall Number
- Z-1398-2024
- Event ID
- 94180
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Becton Dickinson & Co.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- April 10, 2024
- Initiation Date
- February 29, 2024
- Classification Date
- March 29, 2024
- Address
- 7 Loveton Cir, Sparks, MD, 21152-9212, United States
Description
BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermentation, oxidation, degradation, and hydrolysis in combination with chromogenic and fluorogenic substrates along with carbon sources for bacterial identification and quantitation.
Products were found to have confirmed drug cross contamination prior to release may lead to incorrect, inadequate, or absent antibiotic treatment or delay in results
UDI-DI: (10) 3318700 (17)241107 (30)0025 (01) 30382904492923 Lot Number: 3318700 Exp. Date: 07-NOV-2024
Worldwide distribution - US Nationwide and the countries of AR, BE, CO, IN, JP, PE, PY, SG, TW, UY.
11,800 eaches