Recall Z-1544-2018 ยท PPM General Purpose Reagent
Becton Dickinson & Co.
BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
| Date | Mar 2, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Error in labeling |
| Action | 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 wi |
| Quantity | 13,898 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.