FDA Enforcement
Class III
Terminated
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.
Recall: Z-1662-2013
·
Reported July 10, 2013
Enforcement
- Recall Number
- Z-1662-2013
- Event ID
- 65431
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Becton Dickinson & Co.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 10, 2013
- Initiation Date
- May 31, 2013
- Classification Date
- July 3, 2013
- Termination Date
- August 19, 2013
- Address
- BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, 21152-0999, United States
Description
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.
Reason
Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.
Code Info
Serial Numbers: CT0173 to CT0249, CT0253 to CT0260, CT0262, CT0263, CT0265, CT0269, and CT0272
Distribution
Worldwide Distribution - USA Nationwide and in the countries of: Japan, Singapore, Hong Kong, China, Australia, Europe, and Chile.
Quantity
71 instruments