Device 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.
Z-1536-2014
Product summary
- Event
- Event 67948
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 for lot 3295974; 10 of lot 3259822
- Official record key
device-enforcement:Z-1536-2014
Official wording
Reason: Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present in the vial is CD9 PE.
Code information: Catalog number 347211; Lot number 3295974 - expiry date 2015-09-30; Lot number 3259822 - expiry date 2015-09-30.
Distribution pattern: Worldwide Distribution-USA including the states of CA, TX, FL, MO, NY, MI, MO, and AZ and Seoul, Korea.
Derived failure modes
-
Labeling or packaging
mislabeled