FDA-Device2013-07-10Class III
BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.
Becton Dickinson & Co.
Hazard
Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.
Sold states
Worldwide Distribution - USA Nationwide and in the countries of: Japan, Singapore, Hong Kong, China, Australia, Europe, and Chile.
Affected count
71 instruments
Manufactured in
BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, United States
Products
BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1662-2013Don't want to check this manually?
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