# FDA recall Z-1956-2018

> **Roche Molecular Systems, Inc.** · Class II · device recall initiated 2018-05-02.

## 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

## Reason for recall

Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.

## 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.

## Key facts

- **Recall number:** Z-1956-2018
- **Recalling firm:** Roche Molecular Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-02
- **Report date:** 2018-06-06
- **Termination date:** 2019-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Branchburg, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1956-2018

## Citation

> AI Analytics. FDA recall Z-1956-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1956-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*