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U.S. Department of Health and Human Services

Class 3 Device Recall BD MAX DNA MMK (SPC)

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  Class 3 Device Recall BD MAX DNA MMK (SPC) see related information
Date Initiated by Firm March 02, 2018
Create Date April 28, 2018
Recall Status1 Terminated 3 on July 02, 2018
Recall Number Z-1544-2018
Recall Event ID 79769
Product Classification General purpose reagent - Product Code PPM
Product BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
Code Information All since 08/20/2014
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
BD Diagnostic Systems
Sparks MD 21152-9212
For Additional Information Contact BD Customer/Technical Support
800-638-8663
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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