Siemens Atellica CK Reagent Recall: Steady Upward Absorbance Trend

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Recalling firmSiemens Healthcare Diagnostics, Inc.500 Gbc Dr Ms 514, N/A · Newark, DE 19702-2466

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Siemens Healthcare is recalling Atellica CH Creatine Kinase (CK_L) reagents with specific serial numbers because they may show a steady upward trend in blank absorbance. This could lead to inaccurate test results for heart attacks and muscle diseases.

Why it’s dangerous

The reagent may show a steady upward trend in blank absorbance, which could cause inaccurate test results. This might lead to incorrect diagnoses for heart attacks or muscle diseases like Duchenne muscular dystrophy.

Who’s affected

Lab users who purchased the Atellica CH Creatine Kinase reagent with serial numbers 280765, 280766, or 280767 are affected. Those using the reagent for heart attack or muscle disease testing are most at risk.

How to tell if you have this one

Check your reagent's serial number to see if it's 280765, 280766, or 280767. The product is used with ADVIA Chemistry XPT systems for blood tests.

Brand
Siemens Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Look for serial numbers 280765, 280766, or 280767 on the reagent packaging.

✎ GovInfoNow

Questions people ask

What is the product code for this recall?

The product code is 11097640.

What is the UDI number for this recall?

The UDI number is 00630414006642.

What should I do if I have this reagent?

Check if your reagent has serial numbers 280765, 280766, or 280767. If so, contact Siemens Healthcare for guidance.

Take action

Contact Siemens Healthcare

We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1914-2019 — Siemens Healthcare Siemens Healthcare

Hello,

I own a Siemens Healthcare that is covered by recall Z-1914-2019 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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Where this comes from

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.

Official source: FDA Recall #Z-1914-2019 (May 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1914-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The

Lower-risk recall