Siemens Healthcare recalls Atellica CH 930 analyzers due to valve leaks that may cause inaccurate test results. Affected units have specific serial numbers and were sold between 2019 and 2021.
Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.
Siemens Healthcare is recalling Atellica CH 930 analyzers because a manufacturing defect causes valves to leak over time. This leak risk can lead to inaccurate test results, especially in high-pressure situations.
The analyzers' valves can wear and leak due to a manufacturing defect. This leak risk increases when valves are under high pressure or experience high wear, potentially causing inaccurate test results.
Healthcare facilities using the Atellica CH 930 analyzer for clinical testing are most affected. Patients receiving tests on these devices may see inaccurate results due to valve leaks.
Check for serial numbers starting with CM00902 to CM02065. The product was sold between 2019 and 2021 and has a unique identifier (UDI) starting with 00630414002163.
Look for serial numbers in the range CM00902 to CM02065 on the device.
The valves in the Atellica CH 930 analyzers may wear and leak over time due to a manufacturing defect, which can cause inaccurate test results.
Check if your analyzer has a serial number between CM00902 and CM02065, as these units were sold between 2019 and 2021.
The recall record does not specify a remedy, so contact Siemens Healthcare directly for guidance.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2026-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2026-2021 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.
