Siemens Healthcare recalls Atellica CH Enzymatic Creatinine reagent due to potential false low creatinine results for patients on phenindione therapy. No remedy specified in official notice.
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 Atellica CH Enzymatic Creatinine reagent (ECRE_2) because it may give falsely low creatinine test results for patients taking phenindione. This could lead to incorrect treatment decisions if not caught.
The reagent may produce falsely low creatinine readings for patients taking phenindione. This interference does not occur with the creatinine Jaffe methodology. The risk is specific to certain patient populations and testing conditions.
Patients using this reagent for creatinine testing while on phenindione therapy are at risk of inaccurate results. Healthcare providers who order this reagent may need to switch to an alternative testing method.
Check for the Atellica CH Enzymatic Creatinine reagent (ECRE_2) with UDI number 00630414595795. All lots of this product are affected.
Identify if you have the Atellica CH Enzymatic Creatinine reagent (ECRE_2) with UDI number 00630414595795.
The official notice states this reagent may give falsely low creatinine results for patients on phenindione therapy, so it should not be used for those patients.
The recall does not specify a remedy, so no action is required beyond checking if you have the affected reagent.
The official notice does not specify a remedy, so no action is required beyond checking if you have the affected reagent.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1231-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1231-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
