Lower riskMedical device recall · FDA · Published June 24, 2021
Roche cobas infinity software version 3.01.03-3.02.08 may show false test results
Roche recalls cobas infinity lab software versions 3.01.03 to 3.02.08 due to potential false positive or negative test results in specific user scenarios. Affected systems may need software updates to prevent incorrect lab results.
Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be released and interpreted by your Laboratory Information System (LIS) as a false positive or negative result. It should be noted that the "correct" result would still be available on the instrument.
Roche is recalling specific versions of their cobas infinity lab software because it could show false positive or negative test results under certain conditions. This might lead to incorrect lab reports if not fixed, but the correct results are still available on the instrument. Read more at govinfonow.com/recall/62306-roche-cobas-infinity-software-version-3-01-03-3-02.
“Roche cobas infinity software version 3.01.03-3.02.08 may show false test results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62306-roche-cobas-infinity-software-version-3-01-03-3-02. Based on FDA recall #Z-2444-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2444-2021%22&limit=1).
Roche Diagnostics Operations, Inc. recalled cobas infinity central lab running software versions 3.01.03 through 3.02.08 due to potential false positive or negative results, according to the FDA. The recall was announced on June 24, 2021.
How to tell if you have it
Brand: Roche
Product: cobas infinity central lab running software version 3.01.03 through 3.02.08
Catalog#: 07154003001
UDI: 04015630936007
The hazard
Under specific circumstances created by the user, cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be released and interpreted by the Laboratory Information System as a false positive or negative result.
Context
GovInfoNow's records show Roche Diagnostics Operations, Inc. has 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).
How to tell if you have this one
Check if your cobas infinity system has software versions 3.01.03 to 3.02.08. The catalog number 07154003001 or UDI 04015630936007 may also help identify affected units.
Brand
Roche
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your cobas infinity system's software version to see if it falls within 3.01.03 to 3.02.08.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.1 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-2444-2021 (June 24, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2444-2021 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.