BD Phoenix M50 may misidentify E. coli bacteria in clinical samples
The BD Phoenix M50 instruments may misidentify Escherichia coli (E. coli) in clinical samples, potentially causing misdiagnosis and inappropriate treatment. About 4,295 affected units were distributed worldwide.
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 3/5 (High).
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 an FDA Class II recall involving misidentification of E. coli, a high-risk pathogen in clinical settings. While no reported illnesses or injuries are mentioned in the source, the potential for misdiagnosis and inappropriate treatment of E. coli infections poses a significant risk of harm.
Plain-English summary
The BD Phoenix M50 and Phoenix 100 are automated laboratory instruments used in clinical settings to identify bacteria in patient samples and determine their susceptibility to antibiotics. These devices are intended to provide rapid identification results for clinically significant bacteria.
The devices may misidentify Escherichia coli (E. coli) when testing clinical samples. When this misidentification occurs, it could lead clinicians to make incorrect diagnoses and prescribe inappropriate treatments for infections caused by E. coli.
Approximately 4,295 units of the affected BD Phoenix M50 instrument have been distributed worldwide, including throughout the United States and more than 100 countries. The recall affects devices with software version 2.85.0.0 and earlier versions.
Clinical laboratories using affected BD Phoenix M50 or Phoenix 100 instruments should verify that their systems have been updated with current software and should consider reviewing previous E. coli identification results to ensure patient safety.
The recalled product
- Product
- BD Phoenix M50 instrument -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…
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 4,295
Distribution
Distributed nationwide across the United States.
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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