Becton Dickinson & Co.: 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 well

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide and the countries of AR, BE, CO, IN, JP, PE, PY, SG, TW, UY. Quantity: 6700 eaches Lot/code info: UDI-DI: (10) 3312180 (17) 241030 (30)0025 (01) 30382904483167 Lot Number: 3312180 Exp. Date: 30-OCT-2024

UPC codes

30382904483167

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.