Reply to updated IFU and letter
Email
Completed
Andrew,
I think we are good to go. We will not send out a notification, recall or correction either. Our Service Director is copied, and she can inform her team in the event of any inquires and s...
Sending corrected IFU and technical letter
Email
Completed
Hi Patti,
Our team has completed the review of this and updated the IFU to have more clear language. We also issued a technical document explaining the change. We have determined there is no risk...
Added contact: Laura Orlow-Kojac
Contact Management
Completed
Added new contact: Laura Orlow-Kojac, Title: Quality System Manager, Email: LOrlow@CarolinaChemistries.com, Phone: 877-722-8910 ext 21340
Supplier Complaint/Feedback # 25-039
Email
Completed
Good morning Andrew,
Thank you for your quick response.
I have assigned Supplier Complaint/Feedback # 25-039 to address the correction request.
We understand the DCR process takes a few days...
Questioning how to update customers, if UTAK will send it out or if they have to
Email
Completed
Hi Patti,
An official response to this is pending our teams review. Part of our process is a recall and mandatory device reporting evaluation. Based on past experience my best guess is this will ...
Customer found an error on our IFU
Email
Completed
Due Oct 09, 2025
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 I...
rescheduling meeting for first week of Feb
Email
Due Jan 27, 2026
OMG I love ISO audits (Yes I realize this makes me weird) I used to lead our ISO audits and kinda miss that role some days.
I’m sending out an invite for first week of February to get it on our ca...
Reschedule of meeting to discuss a new QC
Email
Completed
Hi Patti,
Thanks for the update! Totally understand things getting busy. The good news is that far out my schedule is wide open. What works for you? I’ll send out a calendar invite once you con...