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U.S. Department of Health and Human Services

Class 2 Device Recall Anti EpCam PE Analyte Specific Reagent Catalog

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 Class 2 Device Recall Anti EpCam PE Analyte Specific Reagent Catalogsee related information
Date Initiated by FirmApril 04, 2014
Date PostedMay 01, 2014
Recall Status1 Terminated 3 on September 28, 2015
Recall NumberZ-1536-2014
Recall Event ID 67948
Product Classification Reagents,specific,analyte - Product Code MVU
ProductAnti 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.
FEI Number 2916837
Recalling Firm/
Manufacturer		 BD Biosciences, Systems & Reagents
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information ContactDiane 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
ActionCustomer product recall notification letters were sent to all consignees on April 4, 2014 by certified mail.
Quantity in Commerce12 for lot 3295974; 10 of lot 3259822
DistributionWorldwide Distribution-USA including the states of CA, TX, FL, MO, NY, MI, MO, and AZ and Seoul, Korea.
Total Product Life CycleTPLC 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.
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