Roche MagNA Pure 96 Instrument Recalled for Cross-Contamination Risk
Roche is recalling 917 MagNA Pure 96 instruments because a specific protocol version fails to activate the drop catcher, posing a risk of cross-contamination and erroneous results.
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 involves a risk of cross-contamination leading to erroneous results, which fits the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Roche Molecular Systems, Inc. is recalling 917 units of the MagNA Pure 96 Instrument, a clinical sample concentrator (Material number 06541089001). The recall is limited to units used with the Sample Transfer protocol version 3.0. The affected instruments were distributed worldwide and nationwide in the United States.
The recall is due to a defect where the drop catcher is not activated when using the specified protocol version. This malfunction introduces a potential risk for cross-contamination, which can lead to erroneous test results. The agency has classified this as a Class II recall.
Users of the MagNA Pure 96 Instrument should check if they are using Sample Transfer protocol version 3.0. If so, they should stop using the instrument with that protocol and contact Roche Molecular Systems, Inc. for further instructions or a remedy.
The recalled product
- 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.
- Manufacturer
- Roche Molecular Systems, Inc.
- Affected units
- 917
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 (1)
- All units when used with Sample Transfer protocol version 3.0
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Roche Molecular Systems, Inc.
See all →- HighRoche cobas Influenza Test Recall Due to False Negative Results
FDA (Devices) · 2023-02-15
- HighRoche Influenza A/B and RSV Test Kit Recalled for False Negative Results
FDA (Devices) · 2023-02-15
- HighRoche cobas Flu/COVID assay recalled for false negative influenza results
FDA (Devices) · 2023-02-15
- HighMedical Device Recall: Roche cobas 5800 False Results Due to Baseline Anomalies
FDA (Devices) · 2022-10-26
- ModerateCobas Liat respiratory virus analyzer units recalled for false Influenza B results
FDA (Devices) · 2022-04-06
Same hazard · cross contamination
See all →- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- ModerateSage Products Recalls Chlorhexidine Gluconate Cloth Due to Cross Contamination
FDA (Drugs) · 2026-09-09
- CriticalCetirizine Hydrochloride Tablets Recalled Due to Cross Contamination with Ranitidine
FDA (Drugs) · 2026-07-29
Similar recalls
- HighRoche MagNA Pure 24 System Recalled for Sample Cross-Contamination
FDA (Devices) · 2018-06-06
- ModerateRoche MagNA Pure 96 System Software Recall
FDA (Devices) · 2012-12-19
- ModerateRoche MagNA Pure LC Software Recall for Diagnostic Issue
FDA (Devices) · 2012-12-19
- HighRoche MagNA Pure 96 System Recalled for Potential Sample Mismatch
FDA (Devices) · 2013-12-25
- ModerateRoche cobas p 612 Pre-Analytical System Recalled for Contamination Risk
FDA (Devices) · 2018-09-05
- HighMedical Device Recall: Roche cobas 5800 False Results Due to Baseline Anomalies
FDA (Devices) · 2022-10-26