BD Biosciences, Systems & Reagents: Medical Device Recall in 2014 - (Recall #: Z-1536-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: April 4, 2014

Date Posted: May 7, 2014

Recall Number: Z-1536-2014

Event ID: 67948

Reason for Recall:

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

Status: Terminated

Product Quantity: 12 for lot 3295974; 10 of lot 3259822

Code Information:

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

Distribution Pattern:

Worldwide Distribution-USA including the states of CA, TX, FL, MO, NY, MI, MO, and AZ and Seoul, Korea.

Voluntary or Mandated:

Voluntary: Firm initiated