A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.
A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send Roche Diagnostics Corporation to request your refund or repair — edit it as you like.
Subject: Recall Z-0499-2018 — Roche Diagnostics Corporation Roche Diagnostics Corporation recalls Roche / Hitachi MODULAR Analyze Hello, I own a Roche Diagnostics Corporation recalls Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - that is covered by recall Z-0499-2018 from Roche Diagnostics Corporation. 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.
