FDAFDA · Food and drugs·Recall number Z-1662-2013
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.
Published July 10, 2013 · Recall initiated: May 31, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Becton Dickinson & Co.
- Distributor
- Worldwide Distribution - USA Nationwide and in the countries of: Japan, Singapore, Hong Kong, China, Australia, Europe, and Chile.
- Lot
- Serial Numbers: CT0173 to CT0249, CT0253 to CT0260, CT0262, CT0263, CT0265, CT0269, and CT0272
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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