Alerta De Seguridad O Notificaciones De Seguridad para CoaguChek Test Strips for Point of Care and Home Use

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

Roche Diagnostics has found an increasing positive bias with INR values above 4.5 for certain CoaguChek test strips. For INR values above 4.5 a medical risk of increased bleeding or thrombosis, due to inadequate therapeutic measures, cannot be excluded.The root cause is multifactorial. The detailed root cause analysis is still ongoing.Users are advised to confirm INR results above 4.5 by a laboratory method (venous blood sample) or unaffected CoaguChek test strips until replacement lots are available. Roche has confirmed that the impacted test strip lots can be used for results between 0.8 to 4.5 INR.MHRA is issuing this Medical Device Alert to make sure users know about this problem, are aware of the follow up FSN issued by Roche and know what updated actions to take. The follow up FSN replaces the one dated 22 August 2018.Roche has indicated that the following new lots, which are unaffected by this issue, are expected to be available to order in early/mid October 2018 for supply to the UK market in November 2018.First new lots which are unaffected by this issue (available in November 2018):CoaguChek XS PT PST Test, lots beginning with 334499xx
CoaguChek XS PT Test, lots beginning with 334499xx
CoaguChek PT Test, lots beginning with 361433xx