Siemens Healthcare recalls Atellica IM 1300 analyzers due to valve leaks that may cause inaccurate test results. Affected units have specific serial numbers and model ranges. Contact for repair or replacement.
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 1300 analyzers because a manufacturing defect causes valves to leak over time. This leak can lead to inaccurate test results if the valve is exposed to high pressure or wear.
The valves in the analyzer may wear and leak due to a manufacturing defect. This leak can cause inaccurate test results when the valve is subjected to high pressure or high wear.
Healthcare facilities using the Atellica IM 1300 analyzer for clinical testing are most likely affected. The risk is low as the leak only impacts test accuracy, not safety.
Check for serial numbers starting with IM00873, IM01452, IRM00256xxxx, or IRM01169xxxx (where xxxx is any number). The UDI is 00630414007960.
Look for specific serial numbers in the affected ranges: IM00873, IM01452, IRM00256xxxx, or IRM01169xxxx (xxxx is any number).
The valves in the Atellica IM 1300 analyzer may wear and leak due to a manufacturing defect, which can lead to inaccurate test results.
Check the serial number for specific patterns: IM00873, IM01452, IRM00256xxxx, or IRM01169xxxx (where xxxx is any number).
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-2027-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2027-2021 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.
