Roche recalls cobas e 411 analyzers with specific catalog numbers due to questionable test results when using 13mm sample tubes without adapters.
Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters.
Roche is recalling certain cobas e 411 analyzers because using 13mm sample tubes without adapters can cause questionable test results. This affects healthcare facilities that use these analyzers for clinical testing.
The hazard occurs when users insert 13mm sample tubes into the analyzer without using the required tube adapters. This can lead to questionable test results because the analyzer may not read the samples correctly.
Healthcare facilities using the recalled cobas e 411 analyzers with specific catalog numbers are most at risk. Patients receiving tests from these devices may see inaccurate results if the issue occurs.
Check the catalog numbers on the analyzer: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system), or 04775279973 (disk system). These models were sold with the issue.
Identify if your analyzer has one of the specific catalog numbers listed: 04775201001 (rack), 04775279001 (disk), 04775201973 (rack), or 04775279973 (disk).
Roche is recalling these analyzers because customers reported questionable test results when using 13mm sample tubes without the required tube adapters.
The recall record does not specify a remedy, so no action is required beyond checking if your analyzer has one of the listed catalog numbers.
Using 13mm sample tubes without adapters can cause questionable results, so it is recommended to use the tube adapters if available.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1270-2018 — Roche Roche Hello, I own a Roche that is covered by recall Z-1270-2018 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.
