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.
The UCFP reagent may cause carryover that affects the next test, leading to falsely low creatinine results. This happens when the UCFP test is run on ADVIA Chemistry systems followed by the Enzymatic Creatinine_2 test.
Healthcare labs using Siemens ADVIA Chemistry systems with the UCFP reagent material number 11319151 are affected. Labs processing urine or cerebrospinal fluid tests with this reagent are most at risk.
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.
Verify the material number on the reagent bottle. If it is 11319151, it is affected.
The reagent may cause false low creatinine results if used in the correct sequence. It is not safe for accurate testing without correction.
Look for the material number 11319151 on the reagent bottle. All lots are affected.
The recall does not specify a remedy, so contact Siemens Healthcare for guidance.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2451-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2451-2023 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.
