Lower riskMedical device recall · FDA · Published October 9, 2020
Roche cobas infinity software may cause incorrect lab results - recall
Roche recalls cobas infinity software versions 3.00.00+ for potential incorrect lab results due to QC status errors. Affected units include specific serial numbers listed in the recall notice.
“Roche cobas infinity software may cause incorrect lab results - recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64104-roche-cobas-infinity-software-may-cause-incorrect-lab-results-recall. Based on FDA recall #Z-0461-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0461-2021%22&limit=1).
Roche Diagnostics Operations, Inc. recalled cobas infinity central lab and core license software applications on Oct. 9, 2020, according to the FDA. The recall addresses potential incorrect validation of results due to an erroneous QC status when using the Status Expiration Control Rule.
How to tell if you have it
Brand: Roche
Product: cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application
Catalog Number: 07154003001
Software versions: cobas infinity version 3.00.00 onwards
The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems. The hazard involves potential incorrect validation of results due to an erroneous QC status when using the Status Expiration Control Rule.
Context
GovInfoNow's records show Roche Diagnostics Operations, Inc. has had 32 other recalls on record since July 2, 2019. Other recent recalls of similar products include Roche cobas pro integrated solutions recall (Jan. 20, 2026), Roche Elecsys Anti-TSHR Assay Recall (Nov. 21, 2025), and Roche cobas HCYS Assay Recall (Oct. 17, 2024). Other recent recalls of similar products include Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall (May 7, 2026), Philips Achieva 3.0T MRI Recalled (Aug. 21, 2026), and Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 DVD Kit (June 26, 2026).
How to tell if you have this one
Check if your cobas infinity software version is 3.00.00 or newer. Look for the specific serial numbers listed in the recall notice (e.g., 82014, 82229, etc.).
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 is 3.00.00 or newer.
Review Serial Numbers
Check if your device has a serial number listed in the recall notice (e.g., 82014, 82229, etc.).
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.7 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-0461-2021 (October 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0461-2021 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.