Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

MagNA Pure 96 Instrument Recalled by Roche Molecular Systems, Inc. Due to When using Sample Transfer protocol version 3.0, the...

Date: June 3, 2020
Company: Roche Molecular Systems, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Roche Molecular Systems, Inc. directly.

Affected Products

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.

Quantity: 917

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Roche Molecular Systems, Inc.

Roche Molecular Systems, Inc. has 42 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report