Siemens Healthcare recalls ADVIA Chemistry Enzymatic Creatinine reagent that may cause false low creatinine results for patients on phenindione therapy. Affected lots are all lots of the reagent.
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 a specific creatinine reagent that may give false low results for patients taking phenindione. This could lead to incorrect treatment decisions if the test results are used without knowing the reagent is faulty.
The reagent may produce falsely low creatinine results for patients taking phenindione. This interference only happens with the enzymatic method, 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 most at risk. Healthcare providers who use the reagent in labs are also affected.
Check if you have the ADVIA Chemistry Enzymatic Creat: ECRE_2 reagent with serial number 00630414526690. All lots of this reagent are affected.
Verify the reagent's serial number is 00630414526690 to confirm it's affected.
The reagent may give false low results for patients on phenindione therapy, so it should not be used without checking the serial number.
Check the serial number; if it's 00630414526690, stop using it and contact Siemens Healthcare for instructions.
No, the interference only occurs with the enzymatic method, not the Jaffe method.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1230-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1230-2020 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.
