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Recall Observatory FDA recall evidence

Device product

BD MAX DNA MMK Lab Use, catalog no. 442828

Z-1545-2018

March 02, 2018

Class III

Product summary

Firm
Becton Dickinson & Co.
Event
Event 79769
Status
Terminated
Classification
Class III
Quantity
N/A
Official record key
device-enforcement:Z-1545-2018

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.