Skip to content
Lower risk Medical device recall · FDA · Published May 2, 2018

Roche MagNA Pure 24 System Recall: Cross-contamination Risk

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.

🇺🇸 FDA recall #Z-1956-2018Medical deviceRoche ›
Take action

Contact the company

Recalling firmRoche Molecular Systems, Inc.1080 US Highway 202 S · Branchburg, NJ 08876-3733
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/71221-roche-magna-pure-24-system-recall-cross-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/71221-roche-magna-pure-24-system-recall-cross-contamination-risk · Updated August 21, 2026 · FDA enforcement record: FDA #Z-1956-2018

Cite this page

“Roche MagNA Pure 24 System Recall: Cross-contamination Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71221-roche-magna-pure-24-system-recall-cross-contamination-risk. Based on FDA recall #Z-1956-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1956-2018%22&limit=1).

Roche Molecular Systems, Inc. recalled the MagNA Pure 24 System on May 2, 2018, after cross-contamination of samples was reported, according to the FDA. The agency announced the Class II recall due to risks associated with the existing protocol on the system.

How to tell if you have it

  • Brand: Roche
  • Product: MagNA Pure 24 System
  • GMMI: 07290519001
  • Device Identifier: 07613336106174

The hazard

Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run, according to the FDA. The record does not report specific incidents or injuries.

Context

GovInfoNow's records show Roche Molecular Systems, Inc. has had 10 other recalls since October 27, 2017. Other recent recalls of similar products include Roche cobas SARS-CoV-2 & Flu Assay Recall (2022-12-21), Roche cobas 5800 PCR device recall (2022-09-08), and Roche cobas LiatSystem recall (2021-11-16). Other recent recalls of similar products include Baxter VOLARA System Recall (2026-08-03), Roche Elecsys Anti-TSHR Assay Recall (2025-11-21), and Roche cobas pro integrated solutions recall (2026-01-20).

How to tell if you have this one

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.

  • Brand
    Roche
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Model Number

    Look for the model number 07290519001 on the device to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 12 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: nationwideILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “Worldwide Distribution - US Nationwide in the states of: CA, GA, HI, IN, MD, ME, MI, MN, NC, NY, PA, VI, and WI. The products were distributed to the following foreign countries: Austria, Belgium, Brazil, Chile, China, Columbia, Costa…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Georgia, Hawaii, Indiana, Maine, Maryland, Michigan, Minnesota, New York, North Carolina, Pennsylvania, Wisconsin.

Recall timeline

FDA terminated this recall 12 months after the firm started it.

1. Firm started the recall: May 2, 201812. FDA classified it Class II: May 30, 201823. Published in FDA’s Enforcement Report: Jun 6, 201834. FDA terminated the recall: Apr 30, 2019420182019
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

Where this comes from

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.

  • Official source: FDA Recall #Z-1956-2018 (May 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1956-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA