MagNA Pure 24 System — Class II medical device recall Z-1956-2018
Terminated recall by Roche Molecular Systems, Inc., reported 2018-06-06, distributed nationwide. Cross-contamination of samples has been reported when running the existing protocol on the system with the rac
| Recall number | Z-1956-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Molecular Systems, Inc., Branchburg, NJ, United States |
| Recall initiated | 2018-05-02 |
| Classified | 2018-05-30 |
| Reported by FDA | 2018-06-06 |
| Terminated | 2019-04-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, BR, CH, CL, CN, CR, CZ, DE, DK, ES, FR, GB, GT, HK, HU, IL, IN, IT, JP, KR, MX, NL, NO, PL, SG, SI, TW, VN, ZA |
| Quantity | 163 units |
| UPC / GTIN / UDI-DI | 07613336106174 |
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.