Z-1544-2018Class III

BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829

Name: Z-1544-2018 BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
Creator: Becton Dickinson & Co.
Published: 2018-03-02
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2018-03-02 / Terminated / root cause: labeling and UDI

FDA source

Becton Dickinson & Co. began a recall of BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829 on 2018-03-02. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1544-2018
Classification: Class III
Status: Terminated
Initiated: 2018-03-02
Posted: 2018-04-28
Terminated: 2018-07-02
Recalling firm: Becton Dickinson & Co
Product: BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
Product code: PPM General Purpose Reagent
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.
Root cause tag: labeling and UDI
FDA 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 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.
Product codes and lots: All since 08/20/2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1544-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1544-2018	Class III	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-28
Z-1545-2018	Class III	Terminated	Voluntary: Firm initiated	2018-05-09	2018-04-28

Product code PPM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)