medical Class II Updated 2024-10-02

Becton Dickinson & Co. recalls BD Phoenix M50 instrument -Intended for the rapid identifica

Recalled 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


Hazard / Issue

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,

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 00382904436247 All serial numbers that have prior Phoenix M50 System Software Version 2.85.0.0 and PUD V7.41A
View official government recall

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