Siemens Healthcare recalls Atellica IM Humidity Packs with software version V1.21.0 or lower due to incorrect expiry detection. This may affect lab testing accuracy.
A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
Siemens Healthcare is recalling Atellica IM Humidity Packs that have software version V1.21.0 or lower. The software error causes the system to incorrectly mark these packs as expired, potentially leading to inaccurate lab test results.
The software error causes the analyzer to incorrectly identify humidity packs as expired. This could lead to the system using expired packs, which might affect the accuracy of clinical test results.
Lab users who have Atellica IM Humidity Packs with software version V1.21.0 or lower are affected. Those using the packs for clinical testing may be at risk of inaccurate results.
Check for the software version label on the humidity pack. Affected packs have software version V1.21.0 or lower. The product was sold with serial number SMN 11313496 and unique identifier UDI 00630414243726.
Look for the software version label on the humidity pack. If it is V1.21.0 or lower, it is affected.
The software error causes the analyzer to incorrectly mark humidity packs as expired, which could lead to inaccurate clinical test results.
Check the software version label on the humidity pack. If it is V1.21.0 or lower, it is affected. The product was sold with serial number SMN 11313496 and unique identifier UDI 00630414243726.
The recall 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-1436-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1436-2020 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.
