Supply Issues Greiner Bio-One Ltd Blood Collection Products Regulatory Inform (ICN 2802)

• The derogation with Blood Collection products from Greiner Bio-One Ltd is continuing.
• The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have extended the derogation deadline to May 2026.
• Three further products have now been delisted and are no longer available to order:
  • KFK302, KFK571 and KFK953.
• One product is now available while our stocks last, once depleted it will be delisted and no longer available to order:
  • KFK593.
• 35 products are now affected by the derogation in total.
• Potential indirect alternative products are available to order through our online catalogue for the affected products. However, some of these products may also become subject to intermittent supply with the increase in demand.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.
• The derogation is anticipated to be resolved by May 2026.

• The derogation with Blood Collection products from Greiner Bio-One Ltd is continuing.
• The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have extended the derogation deadline to 6 January 2026.
• Three affected products have been delisted and are no longer available to order through our online catalogue:
  • KFK252, FNG85020 and FNG85021.
• 39 products remain affected in total.
• Some of the affected products may experience intermittent supply whilst we rebuild stock.
• Potential indirect alternative products are available to order through our online catalogue for most of the affected products. However, some of these products may also become subject to intermittent supply with the increase in demand.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.

• The derogation with Blood Collection products from Greiner Bio-One Ltd is ongoing.
• Due to an unforeseen administrative error during the transition to MDR certification there was a brief interruption to the validity of the CE mark for certain Greiner Bio-One products and as such these lines were suspended from supply to the market.
• A derogation has allowed supply of these products to resume.
• 42 product codes remain affected in total.
• Two affected product codes are now available to order through our online catalogue:
  • FNG85010 and KFK1292.
• 40 product codes remain available to order through our online catalogue.
• However, some of the affected products may experience intermittent supply whilst we rebuild stock.
• Potential indirect alternative products are available to order through our online catalogue for the affected products. However, some of these products may also become subject to intermittent supply with the increase in demand.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.
• We will continue to review the stock to minimise further disruption and will update this ICN as soon as we have further information.
• The next update is anticipated by 31 July 2025.

Change:

• The supplier Greiner Bio-one Ltd has issued a letter to customers having secured a derogation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for a range of their products.
• Due to an unforeseen administrative error during the transition to MDR certification there was a brief interruption to the validity of the CE mark for certain Greiner Bio-One products and as such these lines were suspended from supply to the market.
• The derogation allows supply of these products to resume.
• Please review the official Greiner Bio-One Ltd communication attached for more information.

Impact:

• 42 product codes are affected in total.
• The affected products are available to order through our online catalogue; however, some products may experience intermittent supply whilst we rebuild stock.
• Two of the affected products are currently suspended and unavailable to order:
  • FNG85010 – Blood Collection Set Safety 21G
  • KFK1292 – Blood Collection Set Safety 23G.
• Potential indirect alternative products are available to order through our online catalogue.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.
• We currently do not have a resolution date and will update this ICN when we have further information.

Next Steps:              

• If you have any further questions, please contact your local NHS Supply Chain Customer Services Advisor.
• See our Downloads ▼ section to view the customer letter with further details.
• For any queries, please contact: Enquiries.UK@gbo.com

Please note that due to the clinical nature of these alternative products, we advise you to consult your own clinical experts to ensure suitability for your organisations use of these products.