CoaguChek PT strips recalled
The Medicines and Healthcare products Regulatory Agency has issued a medical device alert regarding the recall of a batch of CoaguChek PT test strips by Roche Diagnostics (see p318).
A defect in the packaging of batch number 583 has been identified, which
may cause falsely high international normalised ratio results. This may
lead to an inappropriate level of anticoagulant treatment and a potentially
increased risk of thrombosis. Roche says that less than 1,000 packs have
been distributed and estimates that 3 per cent of test strips from this
lot are affected.
Pharmacists are asked to contact patients supplied with these strips
since 29 July and advise them to check the lot number on the top of the
carton and on the foil packaging. Patients who have used strips from
the recalled batch should repeat their blood test using a test strip
from a new batch, and contact their general practitioner or anticoagulation
clinic if the result is outside their therapeutic range. Customers can
contact Roche for free-of-charge replacements on 01273 484 863. The test
strips are used with the Roche CoaguChek S monitor.
For further information
is on the Medicines and Healthcare products Regulatory Agency's website. |
