Lower riskMedical device recall · FDA · Published June 3, 2020
Roche MagNA Pure 96 Instrument Recall: Cross-contamination risk with Sample Transfer
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.
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Contact the company
📍Recalling firmRoche Molecular Systems, Inc.1080 US Highway 202 S · Branchburg, NJ 08876-3733
“Roche MagNA Pure 96 Instrument Recall: Cross-contamination risk with Sample Transfer.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65065-roche-magna-pure-96-instrument-recall-cross-contamination-risk-with. Based on FDA recall #Z-2551-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2551-2020%22&limit=1).
Roche Molecular Systems, Inc. recalled the MagNA Pure 96 Instrument due to a potential risk of cross-contamination leading to erroneous results, according to the FDA. The agency announced the Class II recall on June 3, 2020.
How to tell if you have it
Brand: Roche
Product: MagNA Pure 96 Instrument, clinical sample concentrator
Material number: 06541089001
Units affected: 917
The hazard
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.
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 the Roche cobas SARS-CoV-2 & Flu Assay Recall (December 21, 2022), the Roche cobas 5800 PCR device recall (September 8, 2022), and the Roche cobas LiatSystem recall (November 16, 2021). Other recent recalls of similar products include the Baxter VOLARA System Recall (August 3, 2026), the Roche Elecsys Anti-TSHR Assay Recall (November 21, 2025), and the Roche cobas pro integrated solutions recall (January 20, 2026).
How to tell if you have this one
Check if your MagNA Pure 96 instrument is used with Sample Transfer protocol version 3.0. The product was sold with Material number 06541089001.
Brand
Roche
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Protocol Version
Verify if your MagNA Pure 96 instrument uses Sample Transfer protocol version 3.0 by checking the instrument's settings or documentation.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-2551-2020 (June 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2551-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.