What to do if your delivery wasn’t refrigerated straight away

Ahh, you’ve just spotted yesterday’s delivery of CoaguChek® control solution on the side with the paperwork clearly saying “refrigerate on arrival”.

Instant groan… has it all got to go in the bin?


Good news: not necessarily.

There is some built-in tolerance for CoaguChek control solutions being out of the fridge – it just depends on whether the vial has been mixed or is still unmixed.

Below is a clear breakdown of what the different time windows actually mean in practice.

 

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1. Mixed control solution: a strict 30-minute window

The mixed (or reconstituted) control solution is created when you:

1. Take the vial of lyophilised (freeze-dried) control material
2. Add the supplied diluent
3. Gently mix to create a liquid control solution

From this point on, the manufacturer’s guidance is very strict.

What the manufacturer says:
“If the solution has been outside of the refrigerator for more than 30 minutes, it may no longer provide accurate results.”

• Once powder + diluent have been mixed, the chemistry becomes time-limited and temperature-sensitive.
• The stability of the mixed solution is only 30 minutes.
• After 30 minutes at room temperature, the control may no longer perform reliably – and should be discarded.

So, if you mixed a vial yesterday and left it on the bench: unfortunately, that particular mixed control solution is not usable now, even if it’s been put back in the fridge later.
 

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2. Unmixed (lyophilised) control: the more flexible 45-hour window

Standard storage for unmixed vials

• Store at 2–8 °C
• In this state, the product is stable up to the expiry date printed on the pack, as long as the cold chain is broadly maintained

However, cold chain isn’t always perfect in real life – especially during shipping. That’s where the 45-hour allowance comes in.

Roche do not use cooling packs for transport, because the product can safely tolerate a period at higher temperatures while it is still unmixed and lyophilised.
 

• The unmixed product is allowed to be out of refrigerated conditions for up to 45 hours in total during transit.
• This recognises the reality of courier networks, warehouses and delivery vans, where continuous 2–8 °C storage is not always feasible.

Once the product arrives with the customer, it should be placed in the fridge (2–8 °C) as soon as possible to maintain stability going forward.
 

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3. How Ebrington helps protect the cold chain

Although Roche’s own shipping process does not use cooling packs, Ebrington adds an extra margin of safety.
 

• We use cooling packs in our shipments
• These packs are designed to help maintain a cool environment for an additional ~48 hours
• This provides extra reassurance for deliveries that may be delayed in transit or arrive later in the day

This added cooling support sits on top of the manufacturer’s own 45-hour tolerance for unmixed, lyophilised product.
 

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4. So… does your delivery need to be thrown away?

Ask yourself:
 

• Were the vials unopened and unmixed the whole time?
• Has the time from dispatch to you stayed within the expected courier window (normally well under 45 hours)?
• Did the delivery arrive with intact packaging and no obvious heat damage?

If yes, then it’s very likely the product is still usable – just get it into the fridge (2–8 °C) promptly and store it there going forward, following the expiry date on the pack.