Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has bee
FDA device recall Z-1536-2014 · posted 2014-05-01 · Terminated
Recall details
- Recalling firm
- BD Biosciences, Systems & Reagents
- Reason for recall
- Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present in the vial is CD9 PE.
- Action taken
- Customer product recall notification letters were sent to all consignees on April 4, 2014 by certified mail.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- MVU
- Quantity affected
- 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.
- Date initiated
- 2014-04-04
- Date posted
- 2014-05-01
- Date terminated
- 2015-09-28
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.