Table of contents
Overview
The SOM ESM Set Recall Status transaction is an XML-based message used to update the status of serialized pharmaceutical products that have been designated for recall. Working in conjunction with Enterprise Serialization Management (ESM) platforms, this transaction complies with GS1 EPCIS 1.2 standards and ensures that product recall status is captured, traceable, and securely communicated across the supply chain.
This transaction is typically triggered as part of a regulatory recall, or internal QA action, and enables companies to isolate affected units, prevent further distribution, and maintain compliance with DSCSA and global regulatory requirements.
Key Use Cases
- Apply a “recalled” status to serialized units identified in a recall event.
- Prevent further movement, sale, or verification of recalled products.
- Ensure DSCSA and global track and trace compliance by updating product status in real time.
- Synchronize recall status across ERP, WMS, and serialization repositories.
- Maintain a secure, auditable record of recall actions for regulatory inspection.
- Support internal SOPs and regulatory requirements for product quarantine and disposition.
Data Elements Included
An EPCIS 1.2 – SOM ESM Set Recall Status transaction includes:
- Event Type: ObjectEvent with business step “status_update” or “recall_notification”.
- Serialized Product Identifiers (EPCs): SGTINs of the units being marked as recalled.
- Event Time and Time Zone: Timestamp when the recall status was applied.
- Read Point: Location where the recall status was set (e.g., QA, warehouse, compliance office).
- Business Location: GLN or internal site code where the update originated.
- Disposition: Typically “recalled” or “not_for_distribution”.
- Recall Reference ID (optional): Links the status update to a specific recall event or regulatory notice.
- Digital Signature (optional): For regulatory-grade data integrity.
- Reason Code (optional): Explains why the recall status was applied (e.g., “FDA_RECALL”).
- Comments or Notes (optional): Free-text for internal documentation or investigation notes.
Benefits of EPCIS 1.2 – SOM ESM Set Recall Status
- Ensures regulatory compliance by updating recall status in real time for serialized products.
- Provides a secure, auditable record of recall actions for inspections and internal reviews.
- Prevents further distribution or verification of recalled products across the supply chain.
- Integrates with serialization, ERP, WMS, and compliance systems for synchronized status updates.
- Improves visibility and control over recall execution and product disposition.
Business Process: EPCIS 1.2 – SOM ESM Set Recall Status
The SOM ESM Set Recall Status transaction plays a critical role in product recall compliance workflows:
- A product is flagged through customer service, QA, or regulatory channels as requiring recall.
- Serialized units are identified and isolated based on lot, GTIN, or EPC criteria.
- SOM ESM Set Recall Status (EPCIS 1.2) is triggered to apply a “recalled” disposition to the affected EPCs.
- TraceLink updates the serialization repository and alerts relevant systems and partners.
- Units are prevented from being shipped, verified, or sold, and are routed for destruction or return.
- Audit logs are maintained for regulatory inspection and internal compliance reporting.
How TraceLink Supports EPCIS 1.2 – SOM ESM Set Recall Status
TraceLink’s OPUS Platform, powered by B2N Integrate-Once™, supports secure and compliant recall status updates by:
- Triggering recall status updates directly from QA, or regulatory workflows in ESM.
- Capturing EPCIS 1.2-compliant events that mark serialized units as recalled.
- Distributing status updates to internal systems, trading partners, and serialization repositories.
- Providing dashboards and audit logs to monitor recall progress and ensure compliance.
- Ensuring data integrity and traceability through secure, standards-based communication.
Explore More Serialization & Compliance Capabilities
- EPCIS 1.2 SOM Receipt: Confirm receipt of serialized product shipments.
- EPCIS 1.2 SOM ESM Decommission: Deactivate serialized units in the serialization repository.
- EPCIS 1.2 DSCSA ASN: Share serialized shipment data for DSCSA compliance.
Need Help Implementing EPCIS 1.2?
Contact Us to learn how our OPUS Platform and B2N Integrate-Once™ model can help you automate recall status updates, ensure quality and regulatory compliance, and maintain full traceability across your life sciences and healthcare supply chain.
