Siemens Healthcare recalls Atellica IM Humidity Packs with software version V1.21.0 or lower due to incorrect expiry ejection. Affected units may need replacement to prevent reagent analysis errors.
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 a software error causing them to incorrectly eject as expired. This could lead to inaccurate test results if the humidity packs are not properly maintained.
The software error causes the analyzer to mistakenly flag humidity packs as expired. This could lead to improper humidity levels in the reagent compartment, potentially causing inaccurate test results. However, the risk of serious injury is not described in the recall.
Users of Siemens Atellica IM Humidity Packs with software version V1.21.0 or lower are affected. Laboratory personnel who use these packs for clinical testing are most at risk of inaccurate results.
Check for the model number SMN 11313505 and software version V1.21.0 or lower. The humidity packs were sold with lot number 0010.
Verify the software version on your Atellica IM system; versions V1.21.0 or lower are affected.
A software error causes the analyzer to incorrectly eject humidity packs as expired, which could lead to inaccurate test results.
Check for model number SMN 11313505 and software version V1.21.0 or lower, with lot number 0010.
The recall does not specify a remedy, so contact Siemens Healthcare 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-1435-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1435-2020 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.
