Lower riskMedical device recall · FDA · Published December 17, 2020
Roche Cobas Infinity Calculator: Software Error May Cause Incorrect Test Results
Roche recalls Cobas Infinity calculators for clinical use due to a software error that may remove serum indices flags, risking unreliable test results. Affected units include all versions from cobas infinity 3.00.0:00 onwards.
A software error results in the unintentional removal of the serum-indices flag that would otherwise prevent the release of results. The Cobas Inifinity has an auto-verification feature to hold results for manual review when they meet specific criteria. The serum indices flag is used for serum indices tests that are performed to assess the quality of the sample (e.g. hemolysis, icterus, and lipemia). Normally, when the Cobas Infinity receives a result for a test that is serum indices-sensitive, it flags the result and the software then waits for the results of the serum indices tests before validating or rejecting the test result. Roche has discovered a software error that under specific conditions causes the flag to be incorrectly removed. This allows for the possibility that a sample of poor quality may return an unreliable/incorrect test result that is mistakenly reported to the health care provider and/or patient without the proper disclaimer that the result is based on a sample of poor quality.
“Roche Cobas Infinity Calculator: Software Error May Cause Incorrect Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63647-roche-cobas-infinity-calculator-software-error-may-cause-incorrect-test. Based on FDA recall #Z-0883-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0883-2021%22&limit=1).
Roche Diagnostics Operations, Inc. recalled a calculator/data processing module for clinical use due to a software error that may allow unreliable test results to be reported. The FDA announced the voluntary Class II recall on December 17, 2020.
How to tell if you have it
Brand: Roche
Product: A calculator/data processing module for clinical use (Cobas Infinity)
Catalog Number: 07154003001
Version: cobas infinity version 3.00.00 onwards
Quantity: 76 licenses
The hazard
A software error results in the unintentional removal of the serum-indices flag, which normally prevents the release of results for poor-quality samples. This allows the possibility that a sample of poor quality may return an unreliable or incorrect test result that is mistakenly reported to the health care provider and/or patient without the proper disclaimer.
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). Other recent recalls of similar products include Nova Biomedical StatStrip Glucose Meter Software Issue (July 29, 2026) and DxC 500i Clinical Analyzer Modules May Show Incorrect Test Results Due to Software Issue (Sept. 2, 2026).
How to tell if you have this one
Check for the catalog number 07154003001 on the device. Affected units are all versions of the Cobas Infinity calculator from software version 3.00.00 onwards.
Brand
Roche
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Version
Look for the catalog number 07154003001 and software version 3.00.00 or later on the device.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US 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 2.4 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-0883-2021 (December 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0883-2021 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.