Lower riskMedical device recall · FDA · Published September 20, 2021
Siemens Advia UCFP Reagent May Cause False Low A1c Results
Siemens Healthcare recalls Advia UCFP reagents that may produce falsely low hemoglobin A1c results, affecting diabetes management decisions. Affected lots are identified by serial number.
The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.
Siemens Healthcare is recalling Advia Chemistry Urinary/Cerebrospinal Fluid Protein reagents that could cause false low hemoglobin A:1c test results. This might lead to incorrect diabetes treatment decisions if the test results are used without correction. Read more at govinfonow.com/recall/61790-siemens-advia-ucfp-reagent-may-cause-false-low-a1c-results.
“Siemens Advia UCFP Reagent May Cause False Low A1c Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61790-siemens-advia-ucfp-reagent-may-cause-false-low-a1c-results. Based on FDA recall #Z-0181-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0181-2022%22&limit=1).
The FDA announced on Sept. 20, 2021, that Siemens Healthcare Diagnostics is recalling Advia Chemistry Urinary/Cerebrospinal Fluid Protein reagent due to potential carryover affecting Enzymatic Hemoglobin A1c results. The agency issued recall number Z-0181-2022 for the voluntary Class II action.
How to tell if you have it
Brand: Siemens Healthcare
Product: Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP)
Model/Series Number: SMN 11319151
Lot codes: All lots impacted
The hazard
The firm confirmed the potential for reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since June 7, 2017. Recent similar recalls include the Siemens Atellica CH RCRP Test recall (Aug. 17, 2026) and the Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026). Other recent recalls of similar products include the Abbott Diabetes Care FreeStyle Libre 3 Plus Sensor Recall (Nov. 24, 2025) and the Fujirebio Lumipulse pTau 217 Plasma Controls Recall (Dec. 11, 2025).
How to tell if you have this one
Check the serial number on the reagent vial. The affected product is labeled as Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) with serial number SMN 11319151.
Brand
Siemens Healthcare
Category
Medical device
FDA recall event · 2 products
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 distribution - US Nationwide distribution.
Recall number
Product, codes & lots
Quantity
Z-0180-2022
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543; All lots impacted
1402 (US); 2941 (OUS)
Z-0181-2022
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151; All lots impacted
246 (US); 689 (OUS)
Based on the official FDA remedy
What to do — step by step
Check Reagent Serial Number
Look for the serial number SMN 11319151 on the Advia UCFP reagent vial.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0181-2022 (September 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0181-2022 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.