Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Anti EpCam PE Analyte Specific Reagent Catalog

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Anti EpCam PE Analyte Specific Reagent Catalog see related information
Date Initiated by Firm April 04, 2014
Date Posted May 01, 2014
Recall Status1 Terminated 3 on September 28, 2015
Recall Number Z-1536-2014
Recall Event ID 67948
Product Classification Reagents,specific,analyte - Product Code MVU
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.

Code Information Catalog number 347211; Lot number 3295974 - expiry date 2015-09-30; Lot number 3259822 - expiry date 2015-09-30.
Recalling Firm/
Manufacturer		 BD Biosciences, Systems & Reagents
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information Contact Diane Brooks-Smith
408-954-6307
Manufacturer Reason
for Recall		 Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present in the vial is CD9 PE.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-