Siemens recalls Atellica CH 930 analyzers with software V1.25.1 or older due to potential test result errors from reagent expiration and parameter shifts. Affected units may need software update to prevent inaccurate patient results.
(1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magnitude of the implemented Assay Correlation factor; (2) On Board Stability (OBS) Not Updating with Manual Change for Open Channel Assays may continue to use the reagent past its expiration date leading to potential erroneous patient sample results
Siemens is recalling Atellica CH 930 clinical analyzers with software version 1.25.1 or older. These units could show incorrect test results because the software might reset test parameters or let reagents expire before use, risking inaccurate patient diagnoses. Read more at govinfonow.com/recall/61522-siemens-atellica-ch-930-analyzer-software-v1-25-1-recall.
“Siemens Atellica CH 930 Analyzer Software V1.25.1 Recall: Test Errors Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61522-siemens-atellica-ch-930-analyzer-software-v1-25-1-recall. Based on FDA recall #Z-0449-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0449-2022%22&limit=1).
The FDA announced on 2021-11-18 that Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH 930 Analyzers with software version V1.25.1 and lower due to potential erroneous patient results from software defects. The agency issued recall number Z-0449-2022 for the Class II voluntary recall.
How to tell if you have it
Brand: Siemens Healthcare
Product: Atellica CH 930 Analyzer
Software version: V1.25.1 and lower
Siemens Material Number (SMN): 11067000
UDI: 00630414002163
Units affected: 2,980
The hazard
Software versions V1.25.1 and lower may cause Test Definition Parameters for Open Channel Assays to revert to default values, shifting test results by the magnitude of the implemented Assay Correlation factor. Additionally, On Board Stability may not update with manual changes for Open Channel Assays, potentially allowing reagent use past its expiration date and leading to erroneous patient sample results.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has had 150 other recalls on record since 2017-06-07. Recent brand-specific recalls include the Siemens Atellica CH RCRP Test recall from 2026-08-17 and the Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall from 2026-07-13. Other recent recalls of similar products include the Roche cobas pro integrated solutions recall (2026-01-20) and the Beckman Coulter DxC 500i Modules with Software 1.5 Risk (2026-07-15).
How to tell if you have this one
Check for Siemens Healthcare Atellica CH 930 analyzers with software version 1.25.1 or lower. The product has a Siemens Material Number (SMN) 11067000 and UDI 00630414002163.
Brand
Siemens Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Review the software version on your Atellica CH 930 analyzer to confirm if it is 1.25.1 or lower.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide Foreign: AU DE AE TR BG CL IN CZ BR ES KE CN PL SA BE IQ IT CW SE AR CO GR SK EE KR JP UY DK FR GB VN CA BD MX TH DZ PT RU ZA PK HU NL VA NO AT IR LV EG PH SG MY IL FI HR MA KW CH TW BH AL BF UG NZ OM HK QA PE EC IE GP LY LT” 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 published this recall 55 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-0449-2022 (November 18, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0449-2022 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.