Z-1544-2018 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 9, 2018
- Initiation Date
- March 2, 2018
- Termination Date
- July 2, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,898
Product Description
BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
Reason for Recall
The package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution of the master mix tube. Adding the incorrect amount of diluent could have an effect on the assay.
Distribution Pattern
Distributed to accounts in 8 states: CA, FL, NJ, NY, OR, PA, VA, and WI. International distribution to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Europe, Hong Kong, Japan, Singapore, Taiwan, and Thailand.
Code Information
All since 08/20/2014