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

Recall Z-2551-2020 — MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipetting samples into a MagNA Pure 96 Processing Cartridge (purification rack position 1) before a purification run.

U.S. FDA — Device Enforcement · United States · 2020-06-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2551-2020
Date of alert
2020-06-03
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)
06541089001
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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