Siemens recalls Atellica IM 1600 analyzers sold at altitudes over 350m due to reagent overflow errors when pierced. Affected units may show Reagent Volume Check Errors.
Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.
Siemens is recalling Atellica IM 1600 analyzers that may overflow reagent packs at high altitudes, causing error messages. This could lead to inaccurate test results if the analyzer is used at elevations above 350 meters.
Reagent packs used on the analyzer can overflow when pierced at high altitudes, causing the analyzer to display Reagent Volume Check Errors. This may lead to inaccurate test results if the analyzer continues to run without correction.
Users of Atellica IM 1600 analyzers at elevations over 350 meters (1,148 feet) above sea level are most at risk. Laboratories or clinics using these analyzers in high-altitude locations may experience reagent volume errors.
Check if your Atellica IM 1600 analyzer has the model number SMN 11066000. The recall applies to all units sold at elevations above 350 meters (1,148 feet) above sea level.
Verify if your analyzer is used at elevations above 350 meters (1,148 feet) above sea level.
Reagent packs may overflow when pierced at high altitudes, causing Reagent Volume Check Errors in the analyzer.
No, but you should check if your location is above 350 meters. If so, monitor for error messages.
The recall does not require immediate action. Continue using the analyzer but monitor for errors and ensure proper reagent handling.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0125-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0125-2022 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.
