# FDA recall Z-2551-2020

> **Roche Molecular Systems, Inc.** · Class II · device recall initiated 2020-06-03.

## Product

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.

## Reason for recall

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.

## Distribution

Worldwide distribution - US Nationwide distribution.

## Key facts

- **Recall number:** Z-2551-2020
- **Recalling firm:** Roche Molecular Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-03
- **Report date:** 2020-07-22
- **Termination date:** 2023-10-04

- **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-2551-2020

## Citation

> AI Analytics. FDA recall Z-2551-2020. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-2551-2020. Source: US FDA. Licensed CC0.

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