Roche recalls MagNA Pure 96 clinical sample concentrators used with Sample Transfer protocol 3.0 due to cross-contamination risk. Affected units may cause erroneous lab results.
When using Sample Transfer protocol version 3.0, the drop catcher is not activated on the MagNA Pure 96 instrument, which introduces a potential risk for cross-contamination leading to erroneous results.
Roche is recalling MagNA Pure 96 clinical sample concentrators that can cause cross-contamination when used with Sample Transfer protocol version 3.0. This may lead to incorrect lab results if samples are not properly separated.
When using Sample Transfer protocol version 3.0, the drop catcher fails to activate on the MagNA Pure 96 instrument. This causes samples to mix improperly, potentially leading to cross-contamination between samples and incorrect lab results.
Lab technicians and clinical researchers using the MagNA Pure 96 instrument with Sample Transfer protocol version 3.0 are most at risk. The recall affects units sold with this specific protocol.
Check if your MagNA Pure 96 instrument is used with Sample Transfer protocol version 3.0. The product was sold with Material number 06541089001.
Verify if your MagNA Pure 96 instrument uses Sample Transfer protocol version 3.0 by checking the instrument's settings or documentation.
The recall is for potential cross-contamination leading to incorrect lab results, not immediate injury risk. It is a low-risk issue.
Check if your MagNA Pure 96 instrument uses Sample Transfer protocol version 3.0, as the product was sold with Material number 06541089001.
No action is required if you are not using Sample Transfer protocol version 3.0. Only units with this specific protocol are affected.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-2551-2020 — Roche Roche Hello, I own a Roche that is covered by recall Z-2551-2020 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.
