Reliable Temperature & Humidity Monitoring for Diagnostics – From the Lab to the Last Mile

Diagnostic products are only as reliable as the conditions they travel in. From reagent chemical transport to at-home test kit reverse logistics, a single temperature excursion can compromise results, invalidate shipments, and put patients at risk.

SpotSee offers a complete range of cold chain temperature-monitoring devices and temperature and humidity data loggers, purpose-built for the diagnostics industry. Our solutions are simple to use, and require no power source, so your team, your courier, and your end user all know at a glance whether a shipment is still good.

Secure Cold Chain Logistics for Diagnostics

Diagnostic products span a wide range of temperature sensitivities. Whether you are shipping immunoassay reagents at 2–8°C, transporting iSTAT cartridges containing biological samples, or managing the reverse logistics of at-home COVID or glucose test kits, every link in the cold chain carries risk.

SpotSee cold chain temperature monitoring devices are designed to travel with your products, placed directly on the package, inside the box, or attached to the pallet. No power cables. No complex setup. Just clear, actionable data from the moment the shipment leaves your facility.

Products and materials that can be monitored with SpotSee solutions:

  • Blood gas analysis cartridges (e.g., iSTAT) — temperature range 2–32°C

  • Immunoassay and biochemistry reagents — sensitive to both heat and freeze events

  • PCR and molecular diagnostic kits — require a consistent cold chain from production to the end user

  • Lateral flow test kits (rapid antigen, antibody, glucose) — including reverse logistics for at-home testing

  • Biological samples and specimen transport kits

  • Pathology and histology reagents

  • Enzyme-linked assay (ELISA) components

  • Point-of-care (POC) diagnostic devices containing pre-loaded reagents

Our freeze indicators and time over temperature labels provide immediate visibility without a reader device, making them ideal for high-volume shipments where a quick visual check is the most practical quality-control step.

Ensure Safe Pharmaceutical Transportation with SpotSee

Temperature and humidity monitoring in the pharmaceutical industry is no longer optional; it is a regulatory and operational imperative. SpotSee’s product range gives diagnostics companies a scalable toolkit, from single-use indicators to full-featured temperature and humidity data loggers.

Here is how our key products work for diagnostics:

WarmMark® QR

A single-use, battery-free temperature indicator that activates permanently when a warm threshold is exceeded, changing from white to pink/red. Scan the QR code with any smartphone to capture condition, time, date, and location.

ColdMark

Monitors cold temperature exposure. Activates when the product drops below a set threshold. Critical for products where freezing causes irreversible damage, such as liquid reagents and enzyme-based assay components.

FreezeSafe® QR

A single-use freeze indicator that activates permanently when temperatures drop below a defined cold threshold. Scan the QR code with any smartphone to capture condition, time, date, and location, with data uploaded to the SpotSee Cloud.

WarmMark Duo

Monitors two temperature thresholds simultaneously, ideal for iSTAT cartridges and products with complex excursion profiles. One label covers both warm and cold deviation, simplifying inspection at receipt.

Thermax

A maximum temperature indicator for at-home test kit return logistics. Thermax offers a wide range of temperature levels to provide evidence of the highest temperature a shipment has reached, which is critical for validating returned samples or kits before reprocessing.

Maxilog Alert

Multi-use electronic data loggers that record and store temperature and humidity readings over time. Generates PDF and CSV reports for full cold chain documentation, supporting GMP, ISO 17511, and IVDR compliance requirements.

SpotBot® GL

A connected condition monitor tracking tri-axial impact, temperature, humidity, and location in real time via cellular, WiFi, and GPS. Sends live alerts through the SpotSee Cloud whenever a threshold is exceeded. Includes 12-month service plan.

ShockWatch® 2 QR

An impact indicator for shock-sensitive diagnostic devices. Turns red when a g-force threshold is exceeded. Scan the QR code with any smartphone to instantly capture impact condition, time, date, and location via the SpotSee Cloud.

All SpotSee products are engineered for simplicity; your team does not need special training or equipment to deploy them. They are ready to use out of the box and are available in a wide range of standard activation levels to match your industry’s specifications.

Case Study

From 15 Returns a Week to 15 Returns a Quarter

Download the case study to learn:

  • How WarmMark QR helped a pharmacy cut returns by over 90%
  • Why indicator configuration matters as much as monitoring itself
  • How QR-enabled scan records support compliance and quality workflows

A Florida mail-order pharmacy was facing a costly problem: frequent medication returns driven by recorded temperature excursions during direct-to-patient shipments. Many of those returns involved products that were still within acceptable stability limits, meaning the pharmacy was losing revenue and customer trust over false positives.

By switching to WarmMark® QR, the pharmacy gained the right level of visibility into its cold chain, with scan-on-receipt documentation capturing condition, time, date, and location for every shipment. Returns dropped from roughly 15 per week to 15 for an entire quarter, translating into an estimated saving of $180,000 per year.

This case study shows how choosing the right temperature indicator, configured to match your product’s actual stability profile, can reduce unnecessary returns, improve throughput, and strengthen cold chain documentation.

Cold Chain Compliance for Diagnostics

Regulatory bodies worldwide are tightening requirements for in vitro diagnostic (IVD) products and pharmaceuticals in transit. SpotSee solutions are designed to support compliance with the most critical frameworks governing temperature-sensitive diagnostics.

Regulatory Frameworks & Standards

  • EU IVDR (2017/746)

    In Vitro Diagnostic Regulation requires manufacturers to document transport and storage conditions. SpotSee data loggers and indicators provide the audit trail needed to demonstrate cold chain integrity.

  • ISO 17511 / ISO 18113

    Quality management standards for IVD manufacturers — SpotSee products support documentation requirements for metrological traceability and reagent stability.

  • EU GDP Guidelines (Good Distribution Practice)

    Applicable to pharmaceutical and diagnostic product distribution. SpotSee temperature and humidity data loggers generate compliant PDF reports for qualification and batch release.

  • 21 CFR Part 820 (FDA QSR)

    U.S. regulation for medical device manufacturers. SpotSee indicators and loggers provide the condition monitoring records required under device history records.

  • USP <1079>

    Good Storage and Distribution Practices: SpotSee products enable continuous monitoring in line with USP guidance on temperature-sensitive pharmaceutical products.

  • WHO Good Distribution Practices for Pharmaceutical Products

    SpotSee cold-chain tools align with WHO GDP guidance on temperature mapping and excursion documentation.

SpotSee’s temperature and humidity data loggers automatically generate PDF and CSV reports, making it straightforward to provide cold-chain documentation to regulatory inspectors, quality teams, and procurement partners without manual data entry or complex software.

What Our Customers Say

“Since integrating SpotSee’s WarmMark and ColdMark indicators into our reagent packaging, we have dramatically reduced claims for temperature-damaged shipments. The visual simplicity means our logistics partners act immediately — no ambiguity, no delay.”

“SpotSee’s data loggers have transformed how we manage cold chain documentation for our IVD products. Compliance reporting that used to take hours now takes minutes. Our auditors are satisfied, and so are we.”

“The FreezeSafe indicators were exactly what we needed for our enzyme-based assay kits. Simple, reliable, and immediately visible. Our field teams know in seconds whether a kit is still viable.”

Talk to a SpotSee Solutions Specialist

Whether you need a simple freeze indicator for a single reagent kit or a complete cold chain monitoring program for global IVD distribution, SpotSee has the right solution. Our team works closely with diagnostics manufacturers, laboratories, and distributors to find the right fit, fast.

Get in touch today

Tell us about your product and shipping requirements — we’ll recommend the right solution.