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Field Safety Notice Greiner Bio-One Vacuette 2ml 3.2% Citrate 13 x 75mm Blue White Push Cap KFK333 (ICN 2945)

Important Customer Notice Status New Type Product Recall

Ref: 2025/2945 ICN Number: 2945

NHSSC: 22

Alert:

  • Greiner Bio-One has issued a Customer Notification regarding a specific lot of product code KFK333 (supplier code 454322), Vacuette 2ml 3.2% Citrate 13 x 75mm Blue White Push Cap.
  • The supplier has identified that some of the affected tubes, specifically lot number A241137Q, have filled above tolerance level in a limited number of sample collections.
  • It is essential to follow all instructions outlined in the Instructions for Use (IFU), ensuring tubes are not too cold during blood draw.
  • Any tubes from lot A241137Q that exceed the level indicator arrow present on the tube should be discarded right after drawing.

Products Affected:

  • The product affected is available from NHS Supply Chain’s stocked route:

NPC

Product Description Supplier Code / MPC

Affected Lot Number

KFK333

Venous Tube sodium citrate for coagulation Vacuette 2ml 3.2percent Citrate 13 x 75mm Blue White Push Cap 454322

A241137Q

  • Please note only the lot number listed is affected.
  • All NHS Supply Chain stock has been checked and affected products quarantined.
  • Greiner Bio-One confirm there is no impact on availability, future orders will be fulfilled with unaffected batch numbers.

Next Steps:

  • Read and follow the full instructions in the Customer Notification and share with all users of the affected products.
  • Customers are requested to cease use and quarantine all affected product.
  • Contact your local NHS Supply Chain Customer Service Advisor with full details of affected products for return, quoting reason code 7 (Supplier Recall). All products to be returned no later than Friday 6 June 2025.

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.