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Recall Observatory FDA recall evidence

Device 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.

Z-1399-2024

February 29, 2024

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 94180
Status
Ongoing
Classification
Class II
Quantity
6700 eaches
Official record key
device-enforcement:Z-1399-2024

Official wording

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.

Code information: UDI-DI: (10) 3312180 (17) 241030 (30)0025 (01) 30382904483167 Lot Number: 3312180 Exp. Date: 30-OCT-2024

Distribution pattern: Worldwide distribution - US Nationwide and the countries of AR, BE, CO, IN, JP, PE, PY, SG, TW, UY.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    found in A17 well. A17 in yeast