How to track product instructions for IVD kit shipments

Link kit, lot, label conditions, packaging and receipt report in one traceable file.

10 February 2025Updated 23 September 2026

Short answer

Verify transport/storage conditions in the current label and IFU published by the kit manufacturer, matching the kit code and lot; do not assume every IVD product requires cold transport. Plan packing, logger needs, carrier and delivery window from those instructions and receiving laboratory requirements. Record dispatch/receipt times, container ID and package condition. For a deviation, segregate the kit and obtain written assessment from the laboratory quality lead.

Transport conditions for IVD reagents and kits are product-specific; do not begin by assuming cold-chain handling. First match label, product code and lot.

Shipment file. Keep current instructions for use, permitted transport/storage conditions, packaging requirements and receiving laboratory acceptance needs together. Identify reagents, kit components and control material as directed by the instructions.

WHO prequalification guidance for IVDs considers transport stability under realistic temperature/humidity as well as inversion, vibration, physical handling and stacking. Verify tolerance from the manufacturer’s IFU and product-specific study. Add device ID and position to the route record.

At receipt, record product/lot, seal and package condition, time and recipient. For a deviation, segregate the kit from usable stock and preserve data; refer suitability to the manufacturer or laboratory quality lead.