Roche MagNA Pure 24 System Recalled for Sample Cross-Contamination
Roche Molecular Systems is recalling 163 MagNA Pure 24 automated clinical sample extractors due to reported cross-contamination of samples during rack-based purification runs.
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 involves a medical device with a reported functional defect (cross-contamination) that poses a risk of harm to patient care, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Roche Molecular Systems, Inc. is recalling 163 units of the MagNA Pure 24 System, a fully automated clinical sample extractor used to extract nucleic acids from various sample types. The recall is being conducted because cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.
The affected devices were distributed worldwide, including in the United States (CA, GA, HI, IN, MD, ME, MI, MN, NC, NY, PA, VI, and WI) and numerous foreign countries. The specific device identifier for the recalled units is 07613336106174.
Users of the MagNA Pure 24 System should contact Roche Molecular Systems, Inc. for further instructions on how to proceed with the recall and to ensure the safety of their clinical sample processing.
The recalled product
- Product
- MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of…
- Manufacturer
- Roche Molecular Systems, Inc.
- Hazard
- Affected units
- 163
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)
- Device Identifier: 07613336106174
Distribution
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