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FDAFDA · Food and drugs·Recall number Z-1710-2014

Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use.

Published June 11, 2014 · Recall initiated: January 10, 2014

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

Product does not function as intended up to the expiry date on the product labeling. There is a link between the age of the product and staining intensity.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Leica Microsystems, Inc.
Distributor
Worldwide Distribution - US Nationwide in the states of CA, CT FL, IL, MO, MS, NC, NY, PA, and the countries of Argentina, Australia, Brazil, Colombia, Italy, Malaysia, New Zealand, Nigeria, Poland, Romania, Russia, Saudi Arabia, Serbia, South Africa, Sweden, Taiwan, Tunisia, Turkey, and United Kingdom
Lot
Product Code: NCL-L-CD15; Lot Numbers and Expiration Dates: 6017936, Expires 2014-08; 6015073, Expires 2014-03
Risk classification
Class II
Area (FDA)
device
Country
United States

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