Roche Molecular Systems, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2551-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 3, 2020

Date Posted: July 22, 2020

Recall Number: Z-2551-2020

Event ID: 85838

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.

Status: Terminated

Product Quantity: 917

Code Information:

All units when used with Sample Transfer protocol version 3.0

Distribution Pattern:

Worldwide distribution - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated