Siemens Healthcare recalls ADVIA Urea Nitrogen reagent kits for ADVIA 1800/2400/XPT systems due to calibration failures preventing test results.
Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.
Siemens Healthcare is recalling urea nitrogen reagent kits for ADVIA 1800, 2400, and XPT chemistry systems. These kits can cause calibration failures, meaning the system won't generate test results. This affects lab users who rely on accurate blood tests.
The reagent kits can cause calibration failures in the lab systems, which prevents the system from generating test results. This means blood tests for urea nitrogen cannot be completed properly.
Lab technicians and healthcare facilities using ADVIA 1800, 2400, or XPT chemistry systems with the recalled urea nitrogen reagent kits. Users most at risk are those who rely on these systems for blood test results.
Check the material number 10309051 on the reagent kit. The kits were sold with lot numbers 408143 and 418290, expiring June 28, 2018.
Verify the material number is 10309051 and lot numbers are 408143 or 418290.
The reagent kits demonstrated an increased incidence of calibration failures, preventing the system from generating test results.
The system cannot generate test results for urea nitrogen, which affects blood test accuracy.
Check for material number 10309051 with lot numbers 408143 or 418290, expiring June 28, 2018.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2062-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2062-2018 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.
