FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: BD MAX DNA MMK Lab Use, catalog no. 442828
- Recall number
- Z-1545-2018
- Recalling firm
- Becton Dickinson & Co.
- Product
- BD MAX DNA MMK Lab Use, catalog no. 442828
- Status
- Terminated
- Initiated
- 2018-03-02
- Posted
- not on file
- Terminated
- 2018-07-02
- 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 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
- not on file
- 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, serial or model codes
- All since 08/20/2014
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PPM
- Firm FEI
- 1119779
- Firm city
- Sparks
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28