Siemens Healthcare recalls Atellica CH Microalbumin_2 kits for false low microalbumin readings due to Prozone Effect. Affected units have specific lot numbers and were sold with ADVIA Chemistry systems.
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 Atellica CH Microalbumin_2 test kits because they may give false low results for microalbumin in urine. This could lead to incorrect health assessments if used with ADVIA Chemistry systems.
The test kits may produce false low microalbumin readings due to a Prozone Effect, which can happen when the test is used with certain analyzers. This could lead to incorrect health assessments if the test results are relied upon.
Lab users who purchased the Atellica CH Microalbumin_2 kits with lot numbers 232033, 232128, 232137, 232146, 232147, 242149, 242150, or 242365. These kits are used with ADVIA Chemistry systems and Atellica analyzers.
Check the lot number on the kit packaging. Affected kits have lot numbers 232033, 232128, 232137, 232146, 232147, 242149, 242150, or 242365. They were sold with ADVIA Chemistry systems and Atellica analyzers.
Look for the lot numbers 232033, 232128, 232137, 232146, 232147, 242149, 242150, or 242365 on the kit packaging.
The Atellica CH Microalbumin_2 kits may produce false low microalbumin readings due to a Prozone Effect, which can lead to incorrect health assessments.
These kits are used with ADVIA Chemistry systems and Atellica CH and Atellica CI Analyzers.
Check the lot number on the kit packaging. Affected kits have lot numbers 232033, 232128, 232137, 232146, 232147, 242149, 242150, or 242365.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-3169-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-3169-2024 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.
