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New product performance issue
Sep 08, 2025 06:59 PM
Kristin,
Thank you for sharing this feedback and your desired path forward. Please allow me to add @Kevin Kopp from the UTAK team for technical support. Please allow 1-2 business days for our teams response.
Kevin- See below email for lot and analyte issues.
Thank you,
Andrew Hartmann
Business Development Manager
–
25020 Avenue Tibbitts
Valencia, CA 91355
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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: Dragomir-Daescu, Kristin E. <DragomirDaescu.Kristin@mayo.edu>
Sent: Monday, September 8, 2025 1:49 PM
To: Support@UTAK <support@utak.com>; Andrew Hartmann <ahartmann@utak.com>
Cc: Burns, Samuel D. <Burns.Samuel@mayo.edu>; Gaffron, Christopher C. <Gaffron.Christopher@mayo.edu>; DL RST CFTL Quality Specialists <DLRSTCFTLQS@mayo.edu>
Subject: RE: FENTS Control Quote Needed - Quote #5614
Hi Andrew and Team,
We have tested the three levels of the fentanyl serum controls, and unfortunately the targets for the fentanyl analyte are not being hit. Norfentanyl is looking ok, but we would like to request some third-party testing for all three levels. If the third-party testing correlates with our results, we would also then ask that the level 3 be remade as it is too far from the target and cannot be used clinically.
Lot# D7550 D7551 D7552
n C1 avg. C2 avg. C3 avg.
Fentanyl 4 0.12
(47% above target) 1.00
(33% above target) 1.99
(33% above target)
Norfentanyl 4 0.36
(-9% below target) 3.74
(0% below target) 7.49
(0% below target)
Please let me know if there are any questions regarding this.
Thanks,
Kristin