Siemens Healthcare recalls Atellica CH UCFP reagents with specific lot numbers due to potential for biased quality control and patient results. Affected units may need retesting.
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 Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) reagents that could produce inaccurate patient results. This affects specific lot numbers and requires retesting to ensure accurate results.
The reagents may cause biased quality control results, leading to inaccurate patient outcomes. This could affect the reliability of urinary or cerebrospinal fluid protein tests.
Lab users who purchased or use Atellica CH UCFP reagents with lot numbers 130414 or 140 are affected. Patients receiving tests using these reagents may need retesting.
Check for lot numbers 130414 (for Atellica CH UCFP) or 140 (for ADVIA Chemistry UCFP) on the reagent packaging. The Siemens Material Number (SMN) is 11097543.
Look for lot numbers 130414 on Atellica CH UCFP or 140 on ADVIA Chemistry UCFP reagents.
No, but you should retest any patient results using these specific lot numbers to ensure accuracy.
Contact Siemens Healthcare to retest patient results or follow their guidance for affected reagents.
Check the lot number on the reagent packaging: 130414 for Atellica CH UCFP or 140 for ADVIA Chemistry UCFP. The Siemens Material Number (SMN) is 11097543.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-3063-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-3063-2024 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.
