Data Foundry

Medical device recalls 2024

BD Phoenix Yeast ID Panel is a self-inoculating — Class II medical device recall Z-1399-2024

Ongoing recall by Becton Dickinson & Co., reported 2024-04-10, distributed nationwide. Esculin, a substrate used in other panels and normally in A16 well, was found in A17 well. A17 in yeast panels

Recall numberZ-1399-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmBecton Dickinson & Co., Sparks, MD, United States
Recall initiated2024-02-29
Classified2024-03-29
Reported by FDA2024-04-10
DistributedNationwide (US)
Quantity6,700 eaches
Reason classesmicrobial contamination
Pathogensyeast
UPC / GTIN / UDI-DI30382904483167
Lot numbers3312180
Expiration dates2024-10-30

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1399-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.