Siemens Healthcare recalls ADVIA Chemistry Creatine Kinase (CK_L) reagent with specific serial numbers due to potential absorbance trend issues affecting test accuracy. Affected units may produce incorrect results for heart and muscle disease diagnosis.
A steady upward trend in blank (u) absorbance was observed
Siemens Healthcare is recalling specific ADVIA Chemistry Creatine Kinase (CK_L) reagent kits because they may show a steady upward trend in blank absorbance. This could lead to inaccurate test results for heart attacks and muscle diseases. Affected units are those with serial numbers 465336, 465663, or 468449.
The reagent may show a steady upward trend in blank absorbance, which could cause test results to be inaccurate. This might lead to incorrect diagnoses of heart attacks or muscle diseases like Duchenne muscular dystrophy.
Lab users who purchased the ADVIA Chemistry CK_L reagent with serial numbers 465336, 465663, or 468449 are affected. Those using the reagent for heart attack or muscle disease testing are most at risk of inaccurate results.
Check for serial numbers 465336, 465663, or 468449 on the reagent packaging. The reagent is used with ADVIA Chemistry XPT systems for in vitro diagnostic testing.
Look for serial numbers 465336, 465663, or 468449 on the reagent packaging.
The reagent may show a steady upward trend in blank absorbance, which could cause inaccurate test results for heart attacks and muscle diseases.
Serial numbers 465336, 465663, and 468449 are affected.
Inaccurate results could lead to incorrect diagnoses of heart attacks or muscle diseases like Duchenne muscular dystrophy.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1913-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1913-2019 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.
