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FDAFDA · Food and drugs·Recall number Z-1536-2014

Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd) protein in Western Blotting.

Published May 7, 2014 · Recall initiated: April 4, 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

Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present in the vial is CD9 PE.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
BD Biosciences, Systems & Reagents
Distributor
Worldwide Distribution-USA including the states of CA, TX, FL, MO, NY, MI, MO, and AZ and Seoul, Korea.
Lot
Catalog number 347211; Lot number 3295974 - expiry date 2015-09-30; Lot number 3259822 - expiry date 2015-09-30.
Risk classification
Class II
Area (FDA)
device
Country
United States

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