FDA Device recall Z-1399-2024
BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) contai…
- FDA Device
- Class II
- ongoing
- Published 2024-04-10
On 2024-04-10 the FDA classified a Class II recall of BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) contai… by Becton Dickinson And, citing esculin, a substrate used in other panels and normally in A16 well, was found in A17 well. A17 in yeast panels is supposed to be an empty well and is not a part of the normal ID e….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1399-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-29 |
| Published | 2024-04-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
Product
BD Phoenix Yeast ID 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 yeast identification.
Reason
Esculin, a substrate used in other panels and normally in A16 well, was found in A17 well. A17 in yeast panels is supposed to be an empty well and is not a part of the normal ID evaluation. However, A17 is checked for fluorescence and if anything is found, the system will abort the panel with the message Fluorescent interference has been detected . Esculin is expected to trigger this fluorescence and test cancellation.
Identifiers
| code_info | UDI-DI: (10) 3312180 (17) 241030 (30)0025 (01) 30382904483167 Lot Number: 3312180 Exp. Date: 30-OCT-2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1399-2024%22
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