Siemens Healthcare recalls Dimension Enzymatic Creatinine reagent (EZCR) SMN 10471520 due to potential false low creatinine results for patients on phenindione therapy. All lots affected.
There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
Siemens Healthcare is recalling its Dimension Enzymatic Creatinine reagent (EZCR) SMN 10471520 because it may give falsely low creatinine test results for patients taking phenindione. This could lead to incorrect treatment decisions if the test results are used without knowing the interference.
The reagent may produce falsely low creatinine results for patients taking phenindione. This interference does not occur with the creatinine Jaffe methodology. False low results could lead to incorrect treatment decisions.
Patients using this reagent for creatinine testing while on phenindione therapy are most at risk. Healthcare providers who order tests with this reagent may also be affected.
Check for the reagent name 'Dimension Enzymatic Creatinine (EZCR)' and the model number SMN 10471520. All lots of this product are affected.
Identify if you have the Dimension Enzymatic Creatinine (EZCR) reagent with model number SMN 10471520.
This reagent may cause falsely low creatinine results for patients on phenindione therapy.
The recall record does not mention a fix or remedy.
Patients taking phenindione therapy who use this reagent for creatinine testing.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1232-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1232-2020 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.
