BD Phoenix diagnostic systems may misidentify E. coli in clinical samples
The BD Phoenix 100 system may misidentify Escherichia coli in clinical samples, potentially leading to misdiagnosis and inappropriate patient treatment. Becton Dickinson is recalling 764 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II device recall involving potential misidentification of E. coli in diagnostic systems, creating risk of patient harm through misdiagnosis and inappropriate treatment. No reported illnesses or injuries are documented, making this a High severity per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Co. is recalling the BD Phoenix 100 system (Catalog 448100) used for rapid identification and antimicrobial susceptibility testing of bacteria. The system may misidentify Escherichia coli (E. coli) when present in clinical samples.
Misidentification of E. coli can lead to misdiagnosis and inappropriate treatment of infections caused by this organism. Incorrect identification in clinical diagnostics may result in patients receiving ineffective or unsuitable antimicrobial therapy.
The recall affects 764 units with all serial numbers included. The affected devices have been distributed to the United States and numerous countries worldwide, including Canada, Australia, and many European, Asian, and African nations.
The recalled product
- Product
- BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number: 448100
- Manufacturer
- Becton Dickinson & Co.
- Category
- Medical Device
- Hazard
- misidentification
- e-coli
- diagnostic-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 00382904481001 All serial numbers
Distribution
Distributed nationwide across the United States.
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