Becton Dickinson & Co. recalls BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829

Recall date

March 2, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1544-2018

FDA classification

Class III

Brand / firm

Becton Dickinson & Co.

Sold / distributed

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.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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