Agency classClass IIOur severity:High FDA (Devices)·Z-0536-2014·Announced 2013-12-25

Roche MagNA Pure 96 System Recalled for Potential Sample Mismatch

Roche Diagnostics is recalling 27 MagNA Pure 96 Systems due to a software issue that may cause sample mismatches when importing XML files.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of sample mismatch in a medical diagnostic device, which fits the criteria for a High severity score (risk-of-harm products where injury has not yet been reported).

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling 27 units of the MagNA Pure 96 System, Version 1.0, Software Version 2.0. This robotic workstation is used for the automated isolation of nucleic acids from various sample materials. The recall is limited to specific serial numbers distributed across 12 US states, including Alabama, Arizona, California, Connecticut, Georgia, New York, North Carolina, New Jersey, Ohio, Texas, Virginia, and Washington.

The recall is due to a software issue affecting customers who import XML files into the instrument for sample identification. Importing an order file in XML format may result in a wrong sequence of samples in the graphical overview, creating a potential for sample mismatch. This issue is only relevant to users utilizing this specific file import function.

Customers who have imported XML files into the MagNA Pure 96 IVD instrument software should contact Roche Diagnostics for further instructions on how to proceed. The affected units are identified by specific serial numbers listed in the recall documentation.

The recalled product

Product: MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) by the use of the specially designed…
Manufacturer: Roche Diagnostics Operations, Inc.
Category: Medical Device — Laboratory Equipment
Hazard: sample-mismatch
software-error
Affected units: 27

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Serial Numbers 2001
2002
2003
2004
2006
2011
2012
2013
2014
2015
2016
2018
2019
2020
2021
2022
2023
2024
2025
2026

Distribution

Distributed in 12 states:

Same manufacturer · Roche Diagnostics Operations, Inc.

See all →

High
Roche cobas analyzer may repeat previous results for spline calibrated assays
FDA (Devices) · 2026-03-11
High
Thyroid receptor immunoassay recalled over variable results across instrument platforms
FDA (Devices) · 2026-01-14
High
Medical Device Homocysteine Test Assay Recalled for Calibration Defects
FDA (Devices) · 2024-11-27
High
Roche Creatine Kinase test reagents recalled for calibration errors
FDA (Devices) · 2024-10-02
High
Roche Tina-quant D-Dimer Test System Recalled for Inaccurate Results
FDA (Devices) · 2023-11-29

Same hazard · sample mismatch