Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1956-2018 — 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 : Scal

U.S. FDA — Device Enforcement · United States · 2018-05-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1956-2018
Date of alert: 2018-05-02
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Roche Molecular Systems, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 07613336106174

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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