MEDICAL DEVICE ALERT – CoaguChek Test Strips
09 Oct 2018
A medical device alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for certain types of CoaguChek Test Strips for Point of Care and Home Use
MEDICAL DEVICE ALERT
Ref: MDA/2018/033
9 October 2018
CoaguChek Test Strips
(Manufactured by Roche Diagnostics GmbH)
A medical device alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for certain types of CoaguChek Test Strips for Point of Care and Home Use. The affected strips may potentially give false high results for INR values above 4.5 (compared to laboratory results) which may lead to incorrect treatment outcomes.
The table below shows the details of the affected strips:
Product name |
Material number |
Lot No. (1st 6 digits as below) |
CoaguChek XS PT Test PST |
07671679190
07671687019 |
From 272167xx up to 334498xx |
CoaguChek XS PT Test |
04625374190
04625358019
04625315019 |
From 272167xx up to 334498xx |
CoaguChek PT Test |
06688721019 |
From 272170xx up to 353606xx |
Further information can be found on the MHRA section on the GOV.UK website.
Produced by NPA Pharmacy team October 2018.