Supply Issues Greiner Bio-One Ltd Blood Collection Products Regulatory Inform (ICN 2802)
Important Customer Notice Supply Issues
Ref: 2025/2802
ICN Number: 2802
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.