Siemens Healthcare recalls ADVIA Chemistry UCFP reagents with potential for biased quality control and patient results. Affected lots include 130414 and 140. No remedy specified in official notice.
The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.
Siemens Healthcare is recalling ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) reagents that may cause biased quality control and patient results. This affects specific lots produced in 2014. The recall is due to potential inaccuracies in test results.
The reagents may produce biased quality control results, leading to inaccurate patient test outcomes. This could cause misdiagnosis or incorrect treatment decisions if the reagents are used without proper quality control checks.
Healthcare facilities using Siemens ADVIA UCFP reagents with lot numbers 130414 or 140 are affected. Laboratory staff and patients who rely on these reagents for accurate test results are at risk of incorrect results.
Check the lot number on the reagent container. Affected lots are 130414 and 140. The Siemens Material Number (SMN) is 11319151 for these reagents.
Look for lot numbers 130414 or 140 on the reagent container.
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) reagents with lot numbers 130414 or 140.
The official notice does not specify a remedy.
Check the lot number on the reagent container; affected lots are 130414 and 140.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-3064-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-3064-2024 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.
