Field Safety Notice Roche Diagnostics CoaguChek PT PA Faulty Code Chips (ICN 2314)

Alert:

• Roche Diagnostics has issued a Product Alert Notice having detected the printed circuit boards of some code chips with wrong dimensions did not correctly fit into the code chip housing.
• As a result, these faulty code chips may not be able to be inserted into the CoaguChek Pro II meters and the meter cannot read the data on the code chip.
• Roche Diagnostic has performed random checks on a statistically significant number of samples of the affected CoaguChek Controls. The expected error rate of faulty code chips is approximately 2%. Therefore, it cannot be excluded that customers may receive the affected CoaguChek Controls with faulty code chips.

Products Affected:

•  The product affected is available on NHS Supply Chain’s eDirect service:

Next Steps:

• Read and follow the full instructions in the Product Alert Notice and share with all users of the affected products.
• Roche advises Customers to immediately check the code chips for the affected lot number. If the code chip is faulty, another pack of the CoaguChek Controls from the same or another lot should be checked if this is available.
• If another unaffected pack or lot number is not available, users should raise a case via Online Support using their Portal: Roche navify® portal.
• Or telephone Roche Diagnostic’s Technical Support Hotline: 0800 100 19 20 (option 2 – Point of Care), to request a replacement CoaguChek Control pack.

If you have any questions in relation to this notice or require any further information, please contact Roche Diagnostic either by their portal: Roche navify® portal or alternatively contact their Technical Support Hotline UK: 0808 100 19 20 (option 2 – Point of Care).

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or Hospital Care Team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.