Email
ISSUES - UTAK P/Z CAL V12 U F ML Lot D7662
Nov 03, 2025 05:55 PM
Hello,
Apologies for the delay. Reaching out as we are seeing issues with the qualification of the sample vial of UTAK P/Z CAL V12 U F ML Lot D7662.
We are observing low concentration for phenobarbital, -34% from expected.
Please see attached for our testing results. We are still currently running additional investigation on our end but wanted to let you know as soon as possible.
Phenobarbital
10/22/2025 (inst 27) 16923.83577
10/22/2025 (inst 141) 15716.68893
10/22/2025 (inst 109) 16053.02657
10/22/2025 (inst 24) 15430.40149
10/22/2025 (inst 105) 16128.87951
10/23/2025 (inst 9) 16840.24649
10/23/2025 (inst 124) 17110.9493
10/23/2025 (inst 47) 17276.88916
10/23/2025 (inst 27) 16405.64778
10/23/2025 (inst 100) 16594.81944
10/24/2025 (inst 72) 18068.1689
10/24/2025 (inst 17) 16679.35748
10/24/2025 (inst 20) 18225.03242
10/24/2025 (inst 123) 16804.38979
10/24/2025 (inst 62) 17034.97045
10/25/2025 (inst 130) 17009.05236
10/25/2025 (inst 138) 16305.9849
10/25/2025 (inst 129) 17477.13247
10/25/2025 (inst 104) 16981.25984
10/25/2025 (inst 105) 18981.23806
10/27/2025 (INST 104) 15653.45955
10/27/2025 (INST 38) 17092.17499
10/27/2025 (INST 126) 15916.73801
10/27/2025 (INST 125) 17068.18748
10/27/2025 (INST 46) 17875.94069
Average 16866.17887
Expected 25600
SD 845.1390867
CV 5.010850964
% bias -34%
Please let us know if you have any questions.
Thank you,
Sheila Comia
Supervisor, Quality Control
Millennium Health
16981 Via Tazon
San Diego, CA 92127
Office:
Fax: (858) 217-3636
Sheila.Comia@millenniumhealth.com
https://millenniumhealth.com/
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