—#161669

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.

FDA product code: JSO — Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: catalog number 214230, lot 7109502

Why it was recalled

HighPuragar was mislabeled and inadvertently sold as Noble Agar.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

On October 3, 2017 an URGENT MEDICAL DEVICE PRODUCT RECA:LL letter was mailed to customers informing them of the recall and requesting that their inventory be checked for product, which should be quarantined and then thrown away. Also, to share notification of recall to any other customers that may have received product. Firm will replace any discarded inventory. Questions or concerns can be directed to: 1-800-638-8663.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

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

Timeline

Recall initiated: 2017-10-03
Terminated: 2018-10-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161669. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.