Press release

Roche CoaguChek device producing inaccurate results

MHRA are asking people who use the CoaguChek device to check their test strips as a precaution following an alert by the manufacturer Roche.

MHRA logo
MHRA logo

People on blood thinners who use the CoaguChek device to test their blood clotting function are being urged to check their test strips, following an alert by the manufacturer Roche.

CoaguChek XS PT Test, CoaguChek PT Test and CoaguChek XS PT PST test strips may give inaccurate International Normalised Ratio (INR) results, a measurement of how long it takes the blood to clot. This could mean you over or under-dose with anticoagulant medication, which in the short term can cause problems such as blood clots or an increased risk of bleeding.

It is advised anyone whose reading on their test strip is above 4.5 INR should discuss their results with a healthcare professional.

The Medicines and Healthcare products Regulatory Agency (MHRA) is urging users to check the lot numbers of their test strips against the lot numbers listed below. It is estimated that more than 125,000 packs have been affected.

Affected products

Product No Lot No (first 6 digits as below)
CoaguChek XS PT Test PST from 272167xx up to 334498xx
CoaguChek XS PT Test from 272167xx up to 334498xx
CoaguChek PT Test from 272167xx up to 334498xx

John Wilkinson, MHRA’s Director of Medical Devices said:

“If you’re worried about your readings when using these test strips, we’d recommend speaking to your GP, anticoagulant clinic or a pharmacist as soon as possible.

“Patient safety is our highest priority and we strongly encourage anyone to report any issues with this product, or more generally with any medical device, to our Yellow Card Scheme.”

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Published 8 October 2018