Z-1662-2013 Class III Terminated
FDA device recall Z-1662-2013 was initiated by Becton Dickinson & Co. on May 31, 2013 and is designated Class III. Reason for recall: Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled. The recall status is terminated (terminated Aug 19, 2013). Affected quantity: 71 instruments.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 10, 2013
- Initiation Date
- May 31, 2013
- Termination Date
- Aug 19, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71 instruments
Product 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 for Recall
Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.
Distribution Pattern
Worldwide Distribution - USA Nationwide and in the countries of: Japan, Singapore, Hong Kong, China, Australia, Europe, and Chile.
Code Information
Serial Numbers: CT0173 to CT0249, CT0253 to CT0260, CT0262, CT0263, CT0265, CT0269, and CT0272
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1662-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026