Lower riskMedical device recall · FDA · Published September 28, 2021
Siemens Atellica IM 1600 Analyzer Recall: Altitude Overflow Risk
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.
Take action
Contact the company
📍Recalling firmSiemens Healthcare Diagnostics, Inc333 Coney St · East Walpole, MA 02032-1516
“Siemens Atellica IM 1600 Analyzer Recall: Altitude Overflow Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61746-siemens-atellica-im-1600-analyzer-recall-altitude-overflow-risk. Based on FDA recall #Z-0125-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0125-2022%22&limit=1).
The FDA announced on Sept. 28, 2021, that Siemens Healthcare Diagnostics, Inc. is recalling Atellica IM 1600 Analyzers with serial number SMN 11066000 due to potential reagent pack overflow at high altitudes. The agency classified the recall as Class II and ongoing.
How to tell if you have it
Brand: Siemens Healthcare
Product: Atellica IM 1600 Analyzer
Serial Number: SMN 11066000
Units affected: All units (1733 total)
The hazard
Ancillary reagent packs used on the analyzers may overflow when pierced at altitudes greater than 350 meters (1148 feet) above sea level. This issue may cause customers to observe an increased number of Reagent Volume Check Errors.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has had 150 other recalls since June 7, 2017. Recent similar recalls include the Siemens Atellica CH RCRP Test recall on Aug. 17, 2026, and the Beckman Coulter Emit 2000 Quinidine Assay Recall on July 13, 2026. Other recent recalls of similar products include the Siemens ARTIS Icono Biplane Recall (May 20, 2026) and the ConMed AirSeal 5mm Access Port Recall (May 14, 2026).
How to tell if you have this one
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.
Brand
Siemens Healthcare
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Domestic distribution to AZ CA CO GA ID KS MO MT NC NE NM NV OH OK OR PA TN TX UT VA WA WI WY. Foreign distribution worldwide.
Recall number
Product, codes & lots
Quantity
Z-0124-2022
Atellica IM 1300 Analyzer, SMN 11066001; All units
1193
Z-0125-2022
Atellica IM 1600 Analyzer, SMN 11066000; All units.
1733
Based on the official FDA remedy
What to do — step by step
Check Elevation Level
Verify if your analyzer is used at elevations above 350 meters (1,148 feet) above sea level.
Where it went and when
Where it was distributed
Distributed in 23 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Domestic distribution to AZ CA CO GA ID KS MO MT NC NE NM NV OH OK OR PA TN TX UT VA WA WI WY. Foreign distribution worldwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
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.
Official source: FDA Recall #Z-0125-2022 (September 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0125-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.