Recall Z-1536-2014— BD Biosciences, Systems & Reagents
Class II · Terminated
Class II FDA medical device recall by BD Biosciences, Systems & Reagents, initiated 2014-04-04, terminated 2015-09-28. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present in the vial is CD9 PE..
- Recalling firm
- BD Biosciences, Systems & Reagents
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-04
- Terminated
- 2015-09-28
- Firm location
- San Jose, CA, United States
Product description
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.
Reason for recall
Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present in the vial is CD9 PE.
Data sourced from openFDA. This site is unofficial and independent of the FDA.