Field Safety Notice Abbott Diagnostics Infectious Diseases Analyser Test Covid-19 2.0 (ICN 3028)

NHSSC: 52

Alert:

• Abbott Diagnostics has issued a revised Field Safety Notice affecting their infection diseases analyser ancillaries ID NOW™ COVID-19 2.0, and ID NOW™ RSV and ID NOW™ Influenza A and B 2 having discovered specific lot numbers where there is a higher occurrence of invalid rates when compared to the product Instructions for Use.
• Please note the original Field Safety Notice dated March was not shared with NHS Supply Chain as Abbott Diagnostics advise the affected lot numbers were not issued through our service. A copy of this earlier notice is included for information only.
• There is a potential for delay of patient results due to inability to generate a valid result.
• Abbot Diagnostics advise any test result (positive or negative) generated should be considered as valid.

Products Affected:

• One of the products affected has been supplied via NHS Supply Chain’s eDirect  route:

• Please note only the lot number quoted in the Field Safety Notice is affected.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• If you have affected products cease use and destroy in accordance with your local regulations.
• Complete and return to Field.safety.notifications@abbott.com the Customer Reply Form, page 3, appendix ll, whether or not you have affected products.
• If you have products needing replacement, please also complete the Customer Reply Request for Replacement, page 4 and return to Field.safety.notifications@abbott.com.
• Please also contact your local NHS Supply Chain Customer Service Advisor with full details of the products destroyed for replacement, to enable us to help you, as necessary.

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