Siemens Healthcare recalls ADVIA Chemistry Microalbumin_2 for potential erroneous low microalbumin test results due to Prozone Effect. Affected units have specific lot numbers and were sold with certain analyzers.
Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions for Use (IFU) on the Atellica CH, Atellica CI Analyzers, ADVIA 1800 Chemistry Systems, ADVIA 2400 Chemistry Systems, and ADVIA Chemistry XPT Systems, may result in erroneously depressed microalbumin patient results.
Siemens Healthcare is recalling ADVIA Chemistry Microalbumin_2 test kits because they may produce falsely low microalbumin results. This could lead to incorrect health assessments for kidney function, especially in patients with diabetes or kidney disease.
The test kits may show lower microalbumin levels than actually present due to a Prozone Effect. This happens when the test kit reacts with high concentrations of albumin in urine, causing false low readings. The result could lead to incorrect health assessments for kidney function.
Patients using these test kits for urine microalbumin measurement may get inaccurate results. Those with diabetes or kidney disease are most at risk of misdiagnosis.
Check the lot numbers: 612528, 616644, 620971, 623768, 636498, 640513, 658356, 668872. The kits were sold with ADVIA Chemistry systems, Atellica CH, and Atellica CI Analyzers.
Look for lot numbers 612528, 616644, 620971, 623768, 636498, 640513, 658356, or 668872 on the test kit packaging.
The test kits may produce falsely low microalbumin results due to a Prozone Effect, which could lead to incorrect health assessments for kidney function.
Check the lot number on the packaging. If it matches the listed numbers, contact Siemens Healthcare for further instructions.
No, this is a low-risk issue that could lead to inaccurate test results, not physical harm.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-3170-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-3170-2024 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.
