Siemens recalls Atellica IM 1300 analyzers sold at altitudes over 350m due to reagent overflow risk 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 1300 analyzers sold at altitudes above 350 meters because reagent packs can overflow when pierced. This may cause the analyzer to display Reagent Volume Check Errors, potentially leading to inaccurate test results.
Reagent packs used on these analyzers can overflow when pierced at high altitudes. This overflow may cause the analyzer to show Reagent Volume Check Errors, which could lead to inaccurate test results if not addressed.
Users of Atellica IM 1300 analyzers at altitudes over 350 meters (1148 feet) above sea level are most at risk. This includes laboratories or clinics in high-altitude locations.
Check if your Atellica IM 1300 analyzer has the model number SMN 11066001. The recall applies to all units sold at altitudes above 350 meters (1148 feet) above sea level.
Verify if your analyzer is located at an altitude greater than 350 meters (1148 feet) above sea level.
Reagent packs used on Atellica IM 1300 analyzers may overflow when pierced at high altitudes, causing Reagent Volume Check Errors.
The recall does not require immediate action. Check if your analyzer is at an altitude over 350 meters and monitor for Reagent Volume Check Errors.
The recall record does not mention a fix or remedy for this issue.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0124-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0124-2022 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.
