FDA-Device2012-12-26Class II
BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria.
Becton Dickinson & Co.
Hazard
An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
Sold states
Nationwide distribution: USA including states of: AR, CA, KY, OK, RI, WI, and WY.
Affected count
12,250 tests
Manufactured in
BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, United States
Products
BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0570-2013Don't want to check this manually?
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