Siemens Healthcare recalls Dimension Vista Enzymatic Creatinine reagent (SMN 10700444) 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 Vista Enzymatic Creatinine reagent (SMN 10700444) because it may give falsely low creatinine test results for patients taking phenindione. This could lead to incorrect treatment decisions if not addressed.
The reagent may produce falsely low creatinine readings for patients taking phenindione. This interference occurs with the enzymatic method but not the Jaffe method. The issue does not cause immediate harm but could lead to incorrect treatment decisions.
Patients using this reagent for creatinine testing while on phenindione therapy are affected. Those with phenindione prescriptions are most at risk of inaccurate test results.
Check for the reagent name 'Dimension Vista Enzymatic Creatinine (ECREA)' and the serial number SMN 10700444. All lots of this product are affected.
Look for the serial number SMN 10700444 on the reagent packaging.
The recall does not mention any injury risk; it only states potential for false low creatinine results.
No, the reagent may give falsely low creatinine results for patients on phenindione therapy, which could affect treatment decisions.
Check for the reagent name 'Dimension Vista Enzymatic Creatinine (ECREA)' and the serial number SMN 10700444. All lots are affected.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1233-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1233-2020 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.
