Anti EpCam PE — Class II medical device recall Z-1536-2014
Terminated recall by BD Biosciences, Systems & Reagents, reported 2014-05-07, distributed in AZ, CA, FL, MI, MO, NY, TX. Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present in the vial is
| Recall number | Z-1536-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BD Biosciences, Systems & Reagents, San Jose, CA, United States |
| Recall initiated | 2014-04-04 |
| Classified | 2014-05-01 |
| Reported by FDA | 2014-05-07 |
| Terminated | 2015-09-28 |
| Distributed | AZ, CA, FL, MI, MO, NY, TX |
| Countries outside the US | KR |
| Reason classes | labeling |
| Lot numbers | 3259822, 3295974 |
| Model numbers | 347211 |
| Expiration dates | 2015-09-30 |
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 for recall
Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present in the vial is CD9 PE.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1536-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.