Z-1536-2014Class II

Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule...

Name: Z-1536-2014 Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule...
Creator: BD Biosciences, Systems & Reagents
Published: 2014-04-04
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2014-04-04 / Terminated / root cause: labeling and UDI

FDA source

BD Biosciences, Systems & Reagents began a recall of Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd)... on 2014-04-04. FDA classified it as Class II and gives the reason as "Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present in the vial is CD9 PE". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1536-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-04
Posted: 2014-05-01
Terminated: 2015-09-28
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: 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.
Product code: MVU Reagents, Specific, Analyte
Reason for recall: Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present in the vial is CD9 PE.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Customer product recall notification letters were sent to all consignees on April 4, 2014 by certified mail.
Quantity in commerce: 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.
Product codes and lots: Catalog number 347211; Lot number 3295974 - expiry date 2015-09-30; Lot number 3259822 - expiry date 2015-09-30.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1536-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1536-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-07	2014-05-01

Product code MVU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)