FDA recall Z-1545-2018

Product

BD MAX DNA MMK Lab Use, catalog no. 442828

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.

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.

Key facts

Status

Terminated

Initiation date

2018-03-02

Report date

2018-05-09

Termination date

2018-07-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sparks, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1545-2018