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FDAFDA · Food and drugs·Recall number Z-0792-2013

Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus from patient specimens.

Published February 13, 2013 · Recall initiated: December 31, 2012

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

RhMK product fungal contamination.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Diagnostic Hybrids Inc
Distributor
Nationwide Distribution including the states of AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA & WI.
Lot
Model #:49-0600, Lot#, 491206T, 491216; Model #: 49-0600A, Lot#, -A-491206T, -A-491216, -A-491216B; Model #: 49-0102A, Lot#, -A-491206T, -A-491216 and Model #: 49-T075A, Lot#, -A-491206T, -A-491216.
Risk classification
Class III
Area (FDA)
device
Country
United States

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