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New type A submitted, testing is stopped until this is resolved
Sep 11, 2025 02:34 PM
Hi Stephanie,
Thank you for reaching out for support with this and sharing your data. Please allow me to add @Kevin Kopp to this email for technical support. I see that your testing is held up until this is resolved and our team will get back to you as quickly as possible with any follow up questions or next steps.
Thank You,
Andrew Hartmann
Business Development Manager
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25020 Avenue Tibbitts
Valencia, CA 91355
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P +1.888.UTAK.LAB
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Book a Meeting with Me
https://calendly.com/ahartmann-utak/30min
utak.com
From: Stephanie Smith <SmithS12@childrensdayton.org>
Sent: Wednesday, September 10, 2025 3:53 PM
To: Support@UTAK <support@utak.com>
Cc: Laurie Whitt <WhittL@childrensdayton.org>; Thomas Brooks <BrooksT@childrensdayton.org>
Subject: Issue with lot D6255 UTAK Level 3
Importance: High
Utak Support Team,
Our attached New QC range study was from UTAK3 lot D6255 exp 4/31/2027 was ran our 1 box from PO-587683 received in March 2025.
Today, I started using our shipment of UTAK3 lot D6255 exp 4/31/2027 from PO-598552 ordered 7/2/25 received on 7/11/25.
My team made up 2 different vials from 2 separate boxes from shipment received on 7/11/25. I observed my tech properly mix and waited an hour prior to use.
My team also ran the vials on 2 different analyzers. See data below.
PinAAcle 900Z by Perkin Elmer is our instrument we use with the AA, Graphite furnace.
PinAAcle B values vial 1
29.59
26.96
25.86
26.08
PinAAcle B values vial 2
26.04
26.19
24.32
25.91
24.24
PinAAcle A values vial 1
26.12
26.00
PinAAcle A values vial 2
25.62
As of right now, we have stopped testing leads and are holding all the patients.
I need help ASAP.
Thanks,
Stephanie Smith
Core Lab Supervisor/
Implementation Specialist