Reagent Lot Traceability
kit lot genealogy · kit assembly traceability · diagnostic kit traceability · reagent traceability · test kit lot traceability
The records that link each finished diagnostic kit lot to every reagent, control, calibrator, consumable and printed-component lot inside it, and to the customers who received it.
Reagent lot traceability is the ability to go from one finished diagnostic kit lot to every lot that went into it, and back again. A kit is an assembly: bulk reagents formulated from raw materials, controls and calibrators, buffers, consumables such as cassettes or plates, inserts, labels and outer packaging. Each of those carries its own lot and expiry. Kit lot genealogy is the parent-child record that joins them, so a question about any single component lot can be answered in both directions.
Kit assembly is where traceability most often breaks. Components made in-house and components bought in arrive on different timelines and are often assembled in a separate room or shift. A usable record shows which component lots were issued to the assembly order, the quantities used, any substitutions, the line clearance before the run and the label lot printed for the finished kit. The finished kit's expiry is normally bounded by its shortest-dated critical component, so the genealogy also explains the expiry on the label.
A worked example: a buyer reports an unexpected control result. Backward trace identifies the control lot and its raw materials; forward trace from that control lot lists every kit lot that contains it, their quantities on hand and where they shipped. Without the component-level link, the site may need a much broader containment or quarantine while the scope is established.
Regulatory anchors vary by market and product. In the US, IVD labels must carry a lot or control number and expiry under 21 CFR 809.10, and device quality system requirements now sit in the QMSR (21 CFR Part 820, incorporating ISO 13485:2016 by reference since 2 February 2026). In the EU, Regulation (EU) 2017/746 (IVDR) sets labelling and traceability expectations. Which rules apply depends on the product's classification and market, which your regulatory team decides.
Related concepts: lot genealogy, reagent stability, lot-to-lot variability, IVD and UDI. Sources: 21 CFR 809.10, FDA QMSR, Regulation (EU) 2017/746.
- 21 CFR 809.10
- 21 CFR Part 820 (QMSR)
- Regulation (EU) 2017/746
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