Product Recall Abbott Rapid Diagnostics Actim® Partus Test (ICN 2734)

MHRA TBC

NHSSC Ref: 69

Alert:

• Abbott Rapid Diagnostics has received a Field Safety Notice from Actim Oy the manufacturer of Actim® Partus Test, withdrawing one Lot number following stability testing showing the Lot number does not fulfil the required criteria.
• A risk for non-specific binding has been identified. Abbott advise this could cause the appearance of a very faint test line in the results window, indicating a false positive.
• True positive results are still obtained from samples with elevated concentrations of phIGFBP-1.

Products Affected:

• The affected product is available on the eDirect Service from NHS Supply Chain:

• 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.
• Cease use and quarantine the affected Lot number.
• Complete Abbott’s Certificate of Destruction AIL-FM0030 vAH and email the form to: Field.Safety.Notifications@abbott.com.
• Please also contact your local NHS Supply Chain Customer Service Advisor with full details of the affected products in your possession, including product code, Lot numbers and quantity stating whether in box quantity of 10 or eaches.
• Your Customer Service Advisor will give you a unique CMS log number and on receipt of written confirmation, will raise the appropriate credit. This must be in the form of an email, quoting the CMS reference and confirming the disposal is in accordance with your local regulations.

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.