BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
This recall has been terminated (originally issued March 2, 2018).
- Recall Initiated
- March 2, 2018
- Terminated
- July 2, 2018
- Recall Number
- Z-1544-2018
- Quantity
- 13,898
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
All since 08/20/2014
Root Cause
Error in labeling
Action Taken
On March 2, 2018, the firm sent Urgent Medical Device Product Advisory notices to customers via UPS. The notice identified the errors and the correct information, as well as potential health risks. Customers were asked to take the following actions: 1) Share the information with all users of the product within their facility to ensure awareness; 2) Complete the customer response form and return to the recalling firm; and 3) Report any associated adverse health consequences to the recalling firm. The recalling firm is not asking customer to send back product or discard. The recalling firm will provide users with an updated insert when available. BD Customer/Technical Support: 800-638-8663, Monday-Friday, 8:30AM-5PM (EST) for US customers.