Siemens Healthcare recalls IMMULITE and IMMULITE 1000 testosterone test kits that may show 40% higher results than expected, potentially delaying diagnosis. Affected kits have specific lot numbers and expiration dates.
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.
Siemens Healthcare is recalling certain testosterone test kits that may show 40% higher results than actual levels. This could delay diagnosis and require repeat testing. The recall affects specific lot numbers with expiration dates in late 2022.
The recalled test kits may show 40% higher testosterone levels than actual, especially at concentrations of 660 ng/dL and above. This could lead to delayed diagnosis or unnecessary medical interventions if results are not checked against other tests.
People using the IMMULITE or IMMULITE 1000 testosterone test kits with lot numbers 515 (expiring November 30, 2022) or 516 (expiring December 31, 2022) are affected. Those who rely on these tests for medical diagnosis may need repeat testing.
Check the lot number on the kit packaging. Affected kits have lot numbers 515 (expiring November 30, 2022) or 516 (expiring December 31, 2022).
Look for lot numbers 515 or 516 on the test kit packaging.
The recalled test kits may show 40% higher testosterone results than actual levels, which could delay diagnosis and require repeat testing.
Check the lot number on the kit packaging. If it's 515 (expiring November 30, 2022) or 516 (expiring December 31, 2022), contact Siemens Healthcare for instructions.
The recall states the risk is remote and may cause temporary or medically reversible issues, but it could delay diagnosis requiring repeat testing.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0355-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0355-2023 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
