Roche cobas c 6000 and cobas c 8000 modular systems recall: possible sample mismatch issue
Roche recalls cobas c 6000 modular series (e 601) and cobas c 8000 modular series (e 602) systems due to a possible sample mismatch issue on the E170 module. The recall includes specific model numbers and serial numbers.
Lower-risk recall
Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 170 module, cobas e 601 analyzer, or cobas e 602 analyzer due to a software limitation.
Contact the company
What happened, in plain English
Roche is recalling certain cobas c 6000 modular series (e 601) and cobas c 8000 modular series (e 602) systems because of a possible sample mismatch issue on the E170 module. This could lead to inaccurate test results if the software limitation is not addressed. Read more at govinfonow.com/recall/73533-roche-cobas-c-6000-and-cobas-c-8000-modular-systems.
Source Summary by GovInfoNow · govinfonow.com/recall/73533-roche-cobas-c-6000-and-cobas-c-8000-modular-systems · Updated September 21, 2026 · FDA enforcement record: FDA #Z-0378-2018
Cite this page
“Roche cobas c 6000 and cobas c 8000 modular systems recall: possible sample mismatch issue.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73533-roche-cobas-c-6000-and-cobas-c-8000-modular-systems. Based on FDA recall #Z-0378-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0378-2018%22&limit=1).
Why it’s dangerous
The recall states that a possible sample mismatch issue may occur on the E170 module due to a software limitation. This could lead to inaccurate test results if the system is not properly maintained or updated, but it does not involve physical hazards like injury or fire.
Who’s affected
Healthcare professionals and labs using the recalled cobas c 6000 modular series (e 601) and cobas c 8000 modular series (e 602) systems with the specific E170 modules listed in the recall. The risk is low as the issue is a software limitation that may cause inaccurate test results but does not pose a direct safety hazard.
How to tell if you have this one
Check if your system has the E170 module with model numbers listed in the recall (e.g., 03022109001, 03023109973) or the serial numbers provided (e.g., 2072-26, 27P6-20). The recall covers specific cobas c 6000 modular series (e 601) and cobas c 8000 modular series (e 602) systems.
- Brand
Roche- Category
Medical device
What to do — step by step
Check Your System
Verify if your system has the E170 module with the model numbers or serial numbers listed in the recall.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA (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 2.6 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.
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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-0378-2018 (June 29, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0378-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 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.