Becton Dickinson & Co. 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 Number: 443624 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 Number: 443624
Brand
Becton Dickinson & Co.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI: 00382904436247 All serial numbers that have prior Phoenix M50 System Software Version 2.85.0.0 and PUD V7.41A
Becton Dickinson & Co. is recalling BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibili due to Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misd. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli,
Recommended Action
Per FDA guidance
BD issued URGENT: Medical Device Product Correction letter to Distributors and End-users. Letter states reason for recall, health risk and action to take: 1. Immediately inspect your facility to identify if you have the affected product listed above. Reference Attachment 1 to confirm software version. 2. Ensure the contents of this notification are read and understood by those within your organization. 3. Continue use of the instrument. However, confirmatory testing should be performed on any gram-negative organism identified when there is laboratory evidence to suspect E. coli. until BD is able to perform the remediation to correct the issue. 4. It is not necessary to review previous test results and no additional clinical actions are recommended. 5. Share and post this customer letter with the users of this application at your facility and forward to any customers to whom you may have distributed the product to ensure awareness. 6. Complete the attached Customer Response Form and return to the BD contact, whether or not your you have the affected product noted on the form, so that BD may acknowledge your receipt of this notification per FDA requirements. BD has identified the root cause and will implement appropriate corrective actions to prevent recurrence of this issue. BD will contact your facility to schedule a service visit to provide an update to the PUD (Phoenix Update Data) and software to correct this issue. North American Regional Complaint Center Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Complaints when prompted Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com Product Complaints, Technical Questions Recall related questions: BDRC24@bd.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026