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Recall Observatory FDA recall evidence

Device product

Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is essentially free of impurities. It is used in electrophoretic and nutritional procedures and in preparing microbiological culture media when increased purity is required.

Z-0935-2018

October 03, 2017

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 79217
Status
Terminated
Classification
Class II
Quantity
216 bottles
Official record key
device-enforcement:Z-0935-2018

Official wording

Reason: HighPuragar was mislabeled and inadvertently sold as Noble Agar.

Code information: catalog number 214230, lot 7109502

Distribution pattern: USA (nationwide) Distribution to the states of and including Puerto Rico : AL, AZ, CA, FL, GA, IA, IL, IN, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NY, OH, OR, PA,TN, TX, UT, VA, WA

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled