Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total Testosterone

• • Ongoing Z-0355-2023 FDA Class II ·initiated 25 Oct 2022

  Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng/dL (22.9 nmol/L) and above with the IMMULITE/IMMULITE 1000 Total Testosterone Assay when compared to the IMMULITE 2000/IMMULITE 2000 XPi Total Testosterone Assay. Two (2) lots of Total Testosterone assays for the IMMULITE/IMMULITE 1000, kit lots #515 and #516 were actively distributed to customers when the issue was discovered by Siemens, and they are subject to the correction or removal in this recall (867 total quantity of reagents distributed for each lot). The violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. In both males and female, testosterone results are not used in isolation but are interpreted in conjunction with clinical history and symptomology as well as with other laboratory testing (e.g. gonadotropins and other sex steroids). A delay in the diagnosis may be experienced and medical intervention, such as repeat testing may be required.

• • Terminated Z-0528-06 FDA Unclassified (pre-2012) ·initiated 3 Jan 2006

  The reagent for this kit lot (L2KTW 2,6 126) was manufactured with a raw material that can carryover and interfere with DPC Kit IMMULITE 2000 Estradiol (L2KE2) causing a false elevation in the observed estradiol concentration.

510(k) Number

K032881 ↗

FDA Product Code

CDZ

Device Class

Class I

Regulation

21 CFR Part 862.1680

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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