Z-1956-2018Class II

MagNA Pure 24 System, GMMI: 07290519001

Name: Z-1956-2018 MagNA Pure 24 System, GMMI: 07290519001
Creator: Roche Molecular Systems, Inc.
Published: 2018-05-02
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2018-05-02 / Terminated / root cause: software

FDA source

Roche Molecular Systems, Inc. began a recall of MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from... on 2018-05-02. FDA classified it as Class II and gives the reason as "Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1956-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-02
Posted: 2018-05-30
Terminated: 2019-04-30
Recalling firm: Roche Molecular Systems Inc
Product: MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of the system are : Scalable purification of 1 to 24 samples Primary/secondary tube handling Inventory and sample management via barcodes Efficient order management via host The MagNA Pure 24 System offers 4 run types: Purification (rack) run Purification (cartridge) run Post Elution run Sample transfer run
Product code: JJH Clinical Sample Concentrator
Reason for recall: Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: Customers were notified of the field action by letter on 4/27/18. The letter included the following required actions: " If you used the MagNA Pure 24 Pathogen 200 and/or Pathogen 1000 protocols to extract nucleic acids for an assay for a chronic infectious disease (e.g., Hepatitis C Virus), then suspected false positives should be evaluated further following local procedures and retested as necessary. " Complete the attached fax form and fax it to 1-844-861-6232 or email it to [email protected]. " File this Urgent Medical Device Correction (UMDC) for future reference.
Quantity in commerce: 163 units
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 Rica, Czech Republic, Denmark, France, Germany, Guatemala, Hong Kong, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, UAE, United Kingdom, Vietnam.
Product codes and lots: Device Identifier: 07613336106174

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1956-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1956-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-30

Product code JJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)