FDA-Device2018-05-09Class III
BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
Becton Dickinson & Co.
Hazard
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.
Sold states
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.
Affected count
13,898
Manufactured in
7 Loveton Cir, BD Diagnostic Systems, Sparks, MD, United States
Products
BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1544-2018Don't want to check this manually?
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