Siemens Healthcare recalls Atel: 2 (Iron_2) reagents that may cause false high microalbumin results if used immediately after iron tests. Affected lots are listed in the recall notice.
Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.
Siemens Healthcare is recalling Atellica CH Iron_2 reagents that can cause false high microalbumin test results when used right after an iron test. This error only happens if a microalbumin test is run right after an iron test.
The reagent can cause false high microalbumin results when a microalbumin test is run right after an iron test. This happens because of reagent carryover from the iron test to the microalbumin test.
People using Atellica CH Iron_2 reagents for iron testing in labs or clinics who run microalbumin tests immediately after iron tests. The risk is low because the error only occurs under specific testing conditions.
Check if you have Atellica CH Iron_2 reagents with Unique Device Identification (UDI) 00630414596402. All lots are affected.
Verify your Atellica CH Iron_2 reagent lot number matches the affected UDI 00630414596402.
The reagents can cause false high microalbumin results when a microalbumin test is run immediately after an iron test due to reagent carryover.
Check for the Unique Device Identification (UDI) 00630414596402 on the Atellica CH Iron_2 reagents.
No action is needed if you don't run microalbumin tests right after iron tests. The error only occurs under specific testing conditions.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1498-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1498-2022 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.
