BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of

FDA device recall Z-3246-2024 · posted 2024-09-24 · Open, Classified

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

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,

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LON

Quantity affected

4,295 (EA)

Distribution

Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswan

Date initiated

2024-08-01

Date posted

2024-09-24

Location

Sparks, MD

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