Recall Z-1536-2014 ยท MVU Reagents, Specific, Analyte
BD Biosciences, Systems & Reagents
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.
| Date | May 1, 2014 (initiated Apr 4, 2014) |
| Status | Terminated |
| Reason | Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present in the vial is CD9 PE. |
| Root cause | Under Investigation by firm |
| Action | Customer product recall notification letters were sent to all consignees on April 4, 2014 by certified mail. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.