Roche is recalling specific versions of its Cobas Infinity lab software because they have a bug that might cause alarms to be mapped incorrectly. This could lead to missed critical clinical alerts in laboratory settings. Read more at govinfonow.com/recall/66868-roche-cobas-infinity-software-version-2-4-1-2-5.
“Roche Cobas Infinity Software Version 2.4.1-2.5.4 Has Incorrect Alarm Mapping.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66868-roche-cobas-infinity-software-version-2-4-1-2-5. Based on FDA recall #Z-0922-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0922-2020%22&limit=1).
Roche Diagnostics Operations, Inc. recalled Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module for clinical use due to incorrect alarm mapping in software versions 2.4.1 through 2.5.4. The Food and Drug Administration announced the voluntary Class II recall on Oct. 8, 2019.
How to tell if you have it
Brand: Roche
Product: Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use
Material Number: 07154003001
Software Version: 2.4.1 through 2.5.4
Units Affected: 20
The hazard
The recall addresses incorrect alarm mapping caused by using a CommServer Driver with Cobas infinity laboratory solution versions 2.4.1 through 2.5.4.
Context
GovInfoNow's records show Roche Diagnostics Operations, Inc. has issued 32 other recalls since July 2, 2019. Recent similar recalls include the Roche cobas pro integrated solutions recall on Jan. 20, 2026, and the Roche Elecsys Anti-TSHR Assay Recall on Nov. 21, 2025. Other recent recalls of similar products include the GE Medical Systems Portrait Compute V1.2 Software Recall (July 20, 2026) and the GE Medical Systems Portrait Core Services Software V1.0.5 Recall (July 20, 2026).
How to tell if you have this one
Check if you have Cobas Infinity software versions 2.4.1 to 2.5.4. The product is used in clinical laboratory settings and is part of Roche's Cobas Infinity system.
Brand
Roche
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your Cobas Infinity software version by checking the software's version number in the system settings.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 13 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide in the states of AL, CA, GA, IA, IL, KY, MI, MO, MT, NJ, NY, OR, TN” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Georgia, Illinois, Iowa, Kentucky, Michigan, Missouri, Montana, New Jersey, New York, Oregon, Tennessee.
Recall timeline
FDA terminated this recall 12 months 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.
No, you do not need to stop using the software immediately. However, you should check your version and consider updating to a newer version if available.
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-0922-2020 (October 8, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0922-2020 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.