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Terminated

BD MAX DNA MMK Lab Use, catalog no. 442828

FDA Recall Z-1545-2018 · Posted None

Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodePPM
Date Initiated2018-03-02
Date Terminated2018-07-02

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.

Firm 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.

Root Cause

Error in labeling

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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