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.
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
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.
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.
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.
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.
Verify your AssayTip/AssayCup Tray's catalog number and lot numbers to confirm if it is affected.
The AssayTips may have an abnormal internal structure that leads to incorrect patient test results.
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.
The recall record does not specify a remedy, so you should check with Roche Diagnostics Operations, Inc. for further instructions.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0044-2020 — Roche Roche Hello, I own a Roche that is covered by recall Z-0044-2020 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
