Siemens Healthcare recalls Atellica IM 1600 analyzers due to valve leaks causing test result inaccuracies. Affected units have specific serial numbers; contact for remedy.
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 IM 1600 analyzers because a manufacturing defect causes valves to leak over time. This leak can affect test accuracy, especially under high pressure or wear.
The analyzer's valves can wear and leak due to a manufacturing defect. Leaks may cause inaccurate test results, particularly when the valves are under high pressure or experience significant wear.
Healthcare labs using the Atellica IM 1600 analyzer for clinical testing are most affected. Patients relying on accurate diagnostic results may be impacted if the analyzer is used without correction.
Check for the serial numbers starting with IH00876, IH01451, IRH00258xxxx, or IRH01169xxxx (where xxxx is any number). The UDI is 00630414002026.
Look for serial numbers starting with IH00876, IH01451, IRH00258xxxx, or IRH01169xxxx (where xxxx is any number).
The valves in the Atellica IM 1600 analyzer may wear and leak due to a manufacturing defect, which can affect test accuracy.
Check for serial numbers starting with IH00876, IH01451, IRH00258xxxx, or IRH01169xxxx (where xxxx is any number).
The recall record does not specify a remedy, so contact Siemens Healthcare for further instructions.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2028-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2028-2021 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.
