Siemens Atellica CH UCFP Reagents May Cause Biased Patient Results
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.
Lower-risk recall
The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/54382-siemens-atellica-ch-ucfp-reagents-may-cause-biased-patient-results.
Source Summary by GovInfoNow · govinfonow.com/recall/54382-siemens-atellica-ch-ucfp-reagents-may-cause-biased-patient-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3063-2024
Cite this page
“Siemens Atellica CH UCFP Reagents May Cause Biased Patient Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54382-siemens-atellica-ch-ucfp-reagents-may-cause-biased-patient-results. Based on FDA recall #Z-3063-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3063-2024%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Siemens Healthcare- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide - US Nationwide distribution in the states of CA, FL, GA, IA, IL, KY, LA, MS, NJ, NY, NV, PA, TX, VA, PR and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Columbia, Croatia, Cura¿ao, St Eus, Czech Republic, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, India, Ireland, Italy, Jordan, Kenya, Korea, Kuwait, Latvia, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, U.A.E., United Kingdom, Uruguay, Vatikancity.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-3063-2024 | Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543; Siemens Material Number: 11097543; UDI-DI: 00630414279206; Lot number: 130414 | 1,164 units (229 US, 935 OUS) |
| Z-3064-2024 | ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151; Siemens Material Number: 11319151; UDI-DI: 00630414279176; Lot number: 140 | 143 units (17 US, 126 OUS) |
What to do — step by step
Check Reagent Lot Numbers
Look for lot numbers 130414 on Atellica CH UCFP or 140 on ADVIA Chemistry UCFP reagents.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 14 states.
FDA distribution: “Worldwide - US Nationwide distribution in the states of CA, FL, GA, IA, IL, KY, LA, MS, NJ, NY, NV, PA, TX, VA, PR and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Columbia, Croatia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Georgia, Illinois, Iowa, Kentucky, Louisiana, Mississippi, Nevada, New Jersey, New York, Pennsylvania, Puerto Rico, Texas, Virginia.
Recall timeline
FDA published this recall 51 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have the affected reagents?
Contact Siemens Healthcare to retest patient results or follow their guidance for affected reagents.
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Where this comes from
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.
- Official source: FDA Recall #Z-3063-2024 (July 29, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3063-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.