BD Phoenix Yeast ID Panel Recalled for Incorrect Substrate Placement
Becton Dickinson recalls BD Phoenix Yeast ID Panel units (Lot 3312180) due to misplaced esculin substrate that triggers system abortion. No injuries reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II medical device recall with no reported injuries or hospitalizations. Although a manufacturing defect causes system abortion, the automated detection mechanism reliably prevents panels from producing results, preventing diagnostic failure from reaching patient care.
Plain-English summary
The BD Phoenix Yeast ID Panel, manufactured by Becton Dickinson & Co., is being recalled due to a manufacturing defect affecting Lot 3312180 (expiration 30-October-2024). This diagnostic device is used with the BD Phoenix Automated Microbiology System to identify yeast species through biochemical substrate analysis. Approximately 6,700 units were affected.
During manufacturing, esculin—a substrate normally used in other diagnostic panels—was incorrectly placed in well A17 of affected units. Well A17 is designed to be empty and does not participate in normal yeast identification. When the automated system scans A17 for fluorescence, the esculin triggers a false-positive detection, causing the system to abort the test with an error message stating "Fluorescent interference has been detected."
Affected panels were distributed worldwide, including to the United States and the countries of Argentina, Belgium, Colombia, India, Japan, Peru, Paraguay, Singapore, Taiwan, and Uruguay. The system's detection mechanism prevents defective panels from producing results. Users with panels from Lot 3312180 should discontinue use and contact Becton Dickinson & Co. for replacement units. No patient illnesses or injuries have been reported associated with this recall.
The recalled product
- 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…
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 6,700
Distribution
Part of a larger recall action
This product is one of 2 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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