Roche recalls cobas e 801 immunoassay analyzers after complaints of signal drops during bottle changes, which could lead to incorrect medical decisions. Affected units may need repair or replacement.
The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and patient treatment.
Roche is recalling its cobas e 801 immunoassay analyzers due to signal drops that could cause incorrect medical decisions. This affects healthcare facilities using the device for diagnostics.
Signal drops can happen after changing the ProCell II M bottle, potentially leading to incorrect medical decisions. This means test results might not accurately reflect a patient's condition, risking wrong treatments.
Healthcare facilities using the cobas e 801 immunoassay analyzer for medical diagnostics are most likely affected. Patients receiving tests on this device could be impacted if incorrect results occur.
The cobas e 801 immunoassay analyzer is a medical device made by Roche. All units are affected, but the issue occurs during bottle changes.
Look for signal drops after changing the ProCell II M bottle, which may indicate the issue.
The device may experience signal drops during bottle changes, which could lead to incorrect medical decisions. It is not safe to use without addressing the issue.
All cobas e 801 immunoassay analyzers are affected, but the issue occurs specifically when changing the ProCell II M bottle.
The recall does not specify a remedy, so contact Roche directly for guidance on next steps.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1249-2019 — Roche Roche Hello, I own a Roche that is covered by recall Z-1249-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
