Z-1536-2014 Class II Terminated
FDA device recall Z-1536-2014 was initiated by BD Biosciences, Systems & Reagents on April 4, 2014 and is designated Class II. Reason for recall: Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present in the vial is CD9 PE. The recall status is terminated (terminated September 28, 2015). Affected quantity: 12 for lot 3295974; 10 of lot 3259822.
Recall Details
- Product Type
- Devices
- Report Date
- May 7, 2014
- Initiation Date
- April 4, 2014
- Termination Date
- September 28, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 for lot 3295974; 10 of lot 3259822
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.
Reason for Recall
Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present in the vial is CD9 PE.
Distribution Pattern
Worldwide Distribution-USA including the states of CA, TX, FL, MO, NY, MI, MO, and AZ and Seoul, Korea.
Code Information
Catalog number 347211; Lot number 3295974 - expiry date 2015-09-30; Lot number 3259822 - expiry date 2015-09-30.