Roche Cobas 8000 System Software Version 05-02 and 06-03 May Cause Incorrect Test Results
Roche recalls Cobas 8000 Modular Series systems with specific software versions due to potential incorrect test results. Affected units have unique serial numbers listed in the recall notice.
Lower-risk recall
A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect results.
Contact the company
What happened, in plain English
Roche is recalling certain Cobas 8000 Modular Series systems with software versions 05-02 and 06-03 because a software failure might set the system to default settings, leading to incorrect test results. This could affect the accuracy of medical tests. Read more at govinfonow.com/recall/73332-roche-cobas-8000-system-software-version-05-02-and-06.
Source Summary by GovInfoNow · govinfonow.com/recall/73332-roche-cobas-8000-system-software-version-05-02-and-06 · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0675-2018
Cite this page
“Roche Cobas 8000 System Software Version 05-02 and 06-03 May Cause Incorrect Test Results.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73332-roche-cobas-8000-system-software-version-05-02-and-06. Based on FDA recall #Z-0675-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0675-2018%22&limit=1).
Why it’s dangerous
The software failure may reset the system to default settings, causing the device to produce incorrect test results. This could lead to misdiagnosis or inappropriate treatment decisions if the results are used for patient care.
Who’s affected
Healthcare facilities using the Cobas 8000 Modular Series system with the specified software versions are most at risk. Patients relying on these systems for medical testing could receive inaccurate results.
How to tell if you have this one
Check if your Cobas 8000 Modular Series system has software versions 05-02 or 06-03. The recall includes specific serial numbers listed in the notice.
- Brand
Roche- Category
Medical device
What to do — step by step
Check Software Version
Verify your system's software version by checking the device settings or documentation. If it is 05-02 or 06-03, it is affected.
Where it went and when
Where it was distributed
Distributed in 36 states and Puerto Rico.
FDA distribution: “Distributed in 36 states: AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using my Cobas 8000 system immediately?
No, the recall does not require immediate discontinuation. You can continue using the system but should check the software version and follow the action steps.
What should I do if my system has the affected software versions?
Check your system's serial number against the list provided in the recall notice. If it matches, contact Roche for further instructions.
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Where this comes from
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-0675-2018 (July 28, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0675-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 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.