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.
What this means for you
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.
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