FDAClass IIMay 7, 2014

Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is recall: Labeling Error

Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40…

Why was Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog number 347211; Lot number 3295974 - expiry date 2015-09-30; Lot number 3259822 - expiry date 2015-09-30.

Product
Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40…
Recalling firm
BD Biosciences, Systems & Reagents
Quantity
12 for lot 3295974; 10 of lot 3259822
Distribution
Worldwide Distribution-USA including the states of CA, TX, FL, MO, NY, MI, MO, and AZ and Seoul, Korea.
Recall date
May 7, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls