Recall Z-3247-2024 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Becton Dickinson & Co.
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
| Date | Sep 24, 2024 (initiated Aug 1, 2024) |
| Status | Open, Classified |
| Reason | 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, |
| Root cause | Under Investigation by firm |
| Action | 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 ab |
| Quantity | 764 (EA) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Cayman Islands, Chile, China, Colombia |
| FDA record | Open on fda.gov |