Roche AssayTip/AssayCup Tray Recall: Incorrect Patient Results Risk
Roche recalls AssayTip/AssayCup Trays for cobas e 801 modules due to potential incorrect patient results from abnormal internal structure. Affected units include specific catalog and lot numbers.
Lower-risk recall
AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an Abnormal Internal Structure and lead to Incorrect patient results
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What happened, in plain English
Roche is recalling AssayTip/AssayCup Trays used with the cobas e 801 module because they may have an abnormal internal structure that leads to incorrect patient test results. This could affect the accuracy of medical tests and requires immediate attention from users. Read more at govinfonow.com/recall/67226-roche-assaytip-assaycup-tray-recall-incorrect-patient-results-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/67226-roche-assaytip-assaycup-tray-recall-incorrect-patient-results-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0044-2020
Cite this page
“Roche AssayTip/AssayCup Tray Recall: Incorrect Patient Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67226-roche-assaytip-assaycup-tray-recall-incorrect-patient-results-risk. Based on FDA recall #Z-0044-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0044-2020%22&limit=1).
Why it’s dangerous
The AssayTips may have an abnormal internal structure that causes the cobas e 801 module to produce incorrect patient test results. This could lead to inaccurate medical diagnoses if the test results are relied upon.
Who’s affected
Users of the cobas e 801 module in medical labs that use the AssayTip/AssayCup Trays with catalog number 5694302001 and specific lot numbers are affected. Medical professionals handling these test components are most at risk.
How to tell if you have this one
Check if your AssayTip/AssayCup Tray has catalog number 5694302001 and lot numbers 18636170, 18665170, 18667170, 18668170, 18215274, 18245274, 18250274, 18251274, 18252274, 18253274, 18265274, 18271274, or 19209274.
- Brand
Roche- Category
Medical device
What to do — step by step
Check Product Details
Verify your AssayTip/AssayCup Tray's catalog number and lot numbers to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
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 2.9 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
Which medical devices use these AssayTips?
These AssayTips are used with the cobas e 801 module, which is part of the cobas c 8000 MODULAR Analyzer Series for in vitro testing.
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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-0044-2020 (August 13, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0044-2020 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.