Z-1398-2024 Class II Ongoing
FDA device recall Z-1398-2024 was initiated by Becton Dickinson & Co. on Feb 29, 2024 and is designated Class II. Reason for recall: 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 The recall status is ongoing. Affected quantity: 11,800 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 10, 2024
- Initiation Date
- Feb 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,800 eaches
Product 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.
Reason for Recall
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
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of AR, BE, CO, IN, JP, PE, PY, SG, TW, UY.
Code Information
UDI-DI: (10) 3318700 (17)241107 (30)0025 (01) 30382904492923 Lot Number: 3318700 Exp. Date: 07-NOV-2024
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1398-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026