Batch Release & Traceability¶
Every Migibio kit lot is released against a documented specification and remains traceable from the raw materials that made it to the clinic that uses it. This page explains the release process and the traceability chain.
What Is a Batch?¶
A batch (lot) is a defined quantity of product manufactured in a single production cycle from the same raw-material lots, under the same conditions. The lot number printed on every cassette is the key to its entire manufacturing history.
The Batch Record¶
Every lot is documented in a batch record that captures:
- Raw-material lots used (antibody, label, membrane, pads).
- Equipment and line parameters (coating rate, drying conditions, cut width).
- In-process QC results (IPQC checkpoints).
- Operators and timestamps for each stage.
The batch record is the auditable backbone of GMP production.
Release Specification¶
A lot is released only if it meets its release specification — typically:
| Parameter | Release requirement |
|---|---|
| Limit of detection (LOD) | Meets the assay's stated LOD |
| Precision (CV%) | Within the assay's stated range |
| Linearity | Within the stated range across the measuring interval |
| Appearance / packaging | Free of defects; seals intact |
Only after FQC confirms the lot meets every criterion is the COA issued and the lot released.
Certificate of Analysis (COA)¶
Each released lot ships with a COA that lists the lot-specific performance data, including:
- Lot number and expiry date.
- LOD, CV%, and linearity results for that specific lot.
- The QC reference values.
The COA certifies your specific lot — it is more specific than the general product IFU.
Traceability Chain¶
Each cassette carries a lot number that resolves to the full batch record. This one-directional chain enables:
- Recall capability — a specific lot can be isolated if an issue is found.
- Audit support — documented provenance for regulatory or customer audits.
- Dispute resolution — a result can be traced to the exact manufacturing lot.
Retained Samples & Stability¶
- Retained samples: a representative sample of every lot is retained under controlled conditions for the product shelf life.
- Stability monitoring: retained samples are periodically re-tested to confirm the expiry date remains valid.
- Complaint investigation: retained samples let Migibio re-test a specific lot if a customer reports an issue.
FAQ¶
How do I trace my kit to its manufacturing lot? Use the lot number printed on the cassette and pouch; it maps to the full batch record and COA.
Where is the COA? It ships with the lot. Contact martinwang2024@gmail.com for a specific lot's COA.
What is the difference between IFU and COA? The IFU is the how-to procedure; the COA certifies the lot-specific quality data.
For the release criteria data, see the Data Hub.
Authored by: Migibio Clinical & Scientific Affairs, Guangzhou Magic Biotech Co., Ltd.
Reviewed by: Migibio R&D Quality Committee
Last updated: 2026-08-14
Disclosure: Migibio (Guangzhou Magic Biotech Co., Ltd.) is the manufacturer of the FIA680/FIA880 analyzers and FICT reagents referenced in this content. See our Editorial & Review Policy.