FDAClass IIIMay 9, 2018

BD MAX DNA MMK recall

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

Why was BD MAX DNA MMK 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All since 08/20/2014

Product
BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
Recalling firm
Becton Dickinson & Co.
Quantity
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.
Recall date
May 9, 2018
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls