Becton Dickinson & Co.: Medical Device Recall in 2018 - (Recall #: Z-1544-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: March 2, 2018

Date Posted: May 9, 2018

Recall Number: Z-1544-2018

Event ID: 79769

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.

Status: Terminated

Product Quantity: 13,898

Code Information:

All since 08/20/2014

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.

Voluntary or Mandated:

Voluntary: Firm initiated