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Hi Patti, Thanks for raising this concern. I can confirm the storage conditions are between 2-8C. We have opened support ticket# 1010 to investigate and correct this. I’ll send you the updated IFU once complete. Just a heads up to make this change will require our DCR process to edit the template so it may take 2-3 days to get everything completed. If there is anything I can do to support in the meantime, please let me know. Thank you, Andrew Hartmann Business Development Manager – 25020 Avenue Tibbitts Valencia, CA 91355 – D +1.661.567.0667 P +1.888.UTAK.LAB F +1.661.294.9272 – Book a Meeting with Me https://calendly.com/ahartmann-utak/30min utak.com From: Patti Shugart <pattigaull@aol.com> Sent: Tuesday, October 7, 2025 9:57 AM To: Christy Payne <cpayne@carolinachemistries.com> Cc: Laura Orlow-Kojac <lorlow@carolinachemistries.com>; Andrew Hartmann <ahartmann@utak.com> Subject: Re: UTAK Control PI Error We certainly can. Laura, Could you please make this a Supplier Complaint / Feedback to get this corrected. I am also copying my copying Andrew so he can get ahead of this. Andrew, Please see below. Thank you, Patti On Tuesday, October 7, 2025 at 09:58:16 AM EDT, Christy Payne <cpayne@carolinachemistries.com> wrote: Hey Patti, There is an error on the IFU for the UTAK Fentanyl Control. Could we see if UTAK will correct it? They should remove “or below” from line 2 since the material is already thawed. CP Under section V V. STORAGE AND STABILITY: 1. Store fresh frozen control material at or below -10°C (14°F). Stable to expiration date printed on the insert and label. 2. Store thawed control material at or below 2-8°C (35-46°F). See table for thawed stability. Christy Payne BS,MT,(ASCP) Director of Field Service, Training and Technical Support