Lower riskMedical device recall · FDA · Published July 25, 2023
Siemens ADVIA UCFP Reagent May Cause False Low Creatinine Results
Siemens Healthcare recalls ADVIA Chemistry UCFP reagent (Material 11319151) that may cause falsely low creatinine results in urine tests. All lots are affected. Contact for replacement.
There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be observed when the assay is processed after the UCFP test on ADVIA Chemistry systems.
Siemens Healthcare is recalling ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) reagent material number 11319151 because it can cause false low creatinine results when used in certain tests. This affects all lots of the reagent. Using the affected reagent may lead to inaccurate test results. Read more at govinfonow.com/recall/57612-siemens-advia-ucfp-reagent-may-cause-false-low-creatinine-results.
“Siemens ADVIA UCFP Reagent May Cause False Low Creatinine Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57612-siemens-advia-ucfp-reagent-may-cause-false-low-creatinine-results. Based on FDA recall #Z-2451-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2451-2023%22&limit=1).
The FDA announced on July 25, 2023, that Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagents due to potential carryover impacting Enzymatic Creatinine_2 results. The agency classified the Class II recall as voluntary.
How to tell if you have it
Brand: Siemens Healthcare
Product: ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP)
Material Number: 11319151
Lot Numbers: All lots
Units affected: 3067
The hazard
There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be observed when the assay is processed after the UCFP test on ADVIA Chemistry systems.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has had 150 other recalls since June 7, 2017. Recent brand recalls include the Siemens Atellica CH RCRP Test recall on Aug. 17, 2026, and the Siemens Atellica CH Urine Albumin Recall on July 6, 2026. Other recent recalls of similar products include the Beckman Coulter Bicarbonate Reagent recall (Oct. 14, 2025), the Bioporto ProNephro AKI Reagent Kit recall (May 18, 2026), and the Copan Italia DTT Liquid Reagent recall (Oct. 29, 2025).
How to tell if you have this one
Check for the material number 11319151 on the reagent bottle. The reagent is used in urine and cerebrospinal fluid protein tests. All lots are affected.
Brand
Siemens Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Reagent Lot
Verify the material number on the reagent bottle. If it is 11319151, it is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 17 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of CA, CO, CT, FL, GA, IA, MD, MI, NJ, NM, NY, OH, PA, SD, TX, UT, and VA. Global distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Connecticut, Florida, Georgia, Iowa, Maryland, Michigan, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Dakota, Texas, Utah, Virginia.
Recall timeline
FDA published this recall 36 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-2451-2023 (July 25, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2451-2023 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.