Roche recalls MagNA Pure 24 System due to reported cross-contamination of samples during rack-based purification runs. Affected units have specific model numbers and were sold for clinical use.
Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.
Roche is recalling its MagNA Pure 24 System laboratory equipment because it can cause sample cross-contamination when using the rack-based purification protocol. This risk could lead to inaccurate test results and potential health impacts if samples are contaminated.
The system can cause cross-contamination of samples when running the rack-based purification protocol. This means samples may mix with each other, leading to inaccurate test results. The risk is specific to the rack-based purification run and not all system functions.
Laboratory users who own or operate the MagNA Pure 24 System with the specific model number 07290519001 are affected. Clinical staff handling samples during rack-based purification runs are most at risk.
Check for the model number 07290519001 on the MagNA Pure 24 System. The device is a clinical sample extractor used in laboratories for nucleic acid purification.
Look for the model number 07290519001 on the device to confirm if it is affected.
The recall is due to reported cross-contamination of samples when running the rack-based purification protocol on the system.
The affected model number is 07290519001.
The official recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1956-2018 — Roche Roche Hello, I own a Roche that is covered by recall Z-1956-2018 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.
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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.