Field Safety Notice PFSN Accu-Chek® Inform II test strips Issue: Positively biased results due to Open Vials within sealed cartons (ICN 1480)

NHSSC Ref:59

Alert:        

• Roche Diagnostics issued a Field Safety Notice in July 2021 informing customers of the possibility however rare for Accu-Chek® Inform II test strip vials to have opened while still in a sealed carton.
• Accu-Chek® Inform II test strips may give a positively biased results if open vials within sealed cartons are used.
• Inappropriate therapy decisions based on inaccurate results could lead to adverse health consequences.
• This Field Safety Notice was only received by NHS Supply Chain in December 2021.

Products Affected:

• These products are available from NHS Supply Chain:

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products. See our Downloads ▼ section to view the Field Safety Notice.
• Roche Diagnostics is updating product labelling to clarify instructions for handling vials that have opened within sealed cartons.
• Roche Diagnostics will provide test strip replacements to users who have purchased test strip vials which have opened while still in a sealed carton. In this event, please contact Roche via burgesshill.techsupportdocs@roche.com.
• For technical support contact Roche Technical Support Line on telephone 0808 100 19 20 (UK).
• NHS Supply Chain is in contact with Roche to ensure timely receipt of Field Safety Notices in future.

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