FDA Device recall Z-1536-2014
Anti EpCam PE - Analyte Specific Reagent
- FDA Device
- Class II
- terminated
- Published 2014-05-07
On 2014-05-07 the FDA classified a Class II recall of Anti EpCam PE - Analyte Specific Reagent by Bd Biosciences Systems And Reagents, citing two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present in the vial is CD9 PE.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1536-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-04 |
| Published | 2014-05-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bd Biosciences Systems And Reagents |
| Distribution | AZ, CA, FL, MI, MO, NY, TX |
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.
Identifiers
| code_info | Catalog number 347211; Lot number 3295974 - expiry date 2015-09-30; Lot number 3259822 - expiry date 2015-09-30. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1536-2014%22
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