Device product
BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
Z-1544-2018
Product summary
- Event
- Event 79769
- Status
- Terminated
- Classification
- Class III
- Quantity
- 13,898
- Official record key
device-enforcement:Z-1544-2018
Official wording
Reason: 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.
Code information: All since 08/20/2014
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.
Derived failure modes
-
Unknown
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.