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FDAFDA · Food and drugs·Recall number Z-0474-2016

Enterococcus Screen Agar QUAD Plate

Published December 30, 2015 · Recall initiated: June 29, 2015

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. The in-date product may also exhibit breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life.

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
Becton Dickinson & Co.
Distributor
Worldwide Distribution - US (nationwide) Distribution to the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI and WV., and to the countries of : Canada, Colombia, India, Mexico and Europe.
Lot
catalog number 222201. Lot numbers 5064938, 5085954, 5105509, and 5133580
Risk classification
Class II
Area (FDA)
device
Country
United States

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