Lower riskMedical device recall · FDA · Published October 26, 2020
Siemens Atellica IM 130: False test results from custom settings resetting
Siemens recalls Atellica IM 1300 analyzers with software version V1.23.1 or lower that may reset custom settings causing false test results. Affected units have Siemens Material Number 11066001.
Test Definition scanning may reset custom settings to defaults causing falsely low or high results. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values
Siemens is recalling Atellica IM 1300 analyzers with software version V1.23.1 or lower. These devices may reset custom test settings when scanning new reagent kits, leading to inaccurate test results. This could affect medical testing accuracy for clinical specimens. Read more at govinfonow.com/recall/64053-siemens-atellica-im-130-false-test-results-from-custom-settings.
“Siemens Atellica IM 130: False test results from custom settings resetting.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64053-siemens-atellica-im-130-false-test-results-from-custom-settings. Based on FDA recall #Z-0473-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0473-2021%22&limit=1).
Siemens Healthcare Diagnostics, Inc. recalled Atellica IM 1300 Analyzers on Oct. 26, 2020, according to the FDA. The hazard involves test definition scanning resetting custom settings, causing falsely low or high results.
How to tell if you have it
Brand: Siemens Healthcare
Product: Atellica IM 1300 Analyzer
Siemens Material Number (SMN): 11066001
Software version: V1.23.1 or lower
UDI: 00630414007960
The hazard
Test Definition scanning may reset custom settings to defaults causing falsely low or high results. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since 2026-08-17. Other recent recalls of similar products include Beckman Coulter DxC 500i Modules with Software 1.5 Risk: Erroneous Test Results (2026-07-15) and Roche Elecsys Anti-TSHR Assay Recall: Inconsistent Results Risk Incorrect Diagnosis (2025-11-21).
How to tell if you have this one
Check for Siemens Material Number 11066001 and software version V1.23.1 or lower. The device is an automated immunoassay analyzer for clinical specimen testing.
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
Terminated
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Peru, Poland, Portugal, Qatar Republic, Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay, Vatikancity, Vietnam.
Recall number
Product, codes & lots
Quantity
Z-0473-2021
Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001; Software version: V1.23.1 or lower UDI: 00630414007960
US 392 units; OUS 449 units
Z-0474-2021
Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066000; Software version: V1.23.1 or lower UDI: 00630414002026
US: 214 units; OUS: 1082 units
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version is V1.23.1 or lower by checking the device's settings menu.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0473-2021 (October 26, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0473-2021 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.