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BioMerieux issues recall due to potential inaccurate test results

The NucliSENS easyMAG system. Picture: bioMerieux

BioMerieux has expanded a recall due to a problem with the magnetic silica (MagSil) component.

The NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents with distribution dates 3 May to 18 August 2016 are affected.

NucliSENS easyMAG is an in vitro diagnostic (IVD)-labeled automated system for total nucleic acid extraction from a variety of sample types and volumes which could then be used for molecular oncology and molecular genetics assays.

The NucliSENS Magnetic Extraction Reagents enable the automated extraction of RNA/DNA from biological samples.

The US Food and Drug Administration (FDA) identified it as a Class I recall, the most serious type, meaning use of the devices may cause serious injuries or death.

MagSil is used to extract and purify genetic material from patient samples.

Affected kits may not be able to fully extract nucleic acids from the sample and detect infection or provide proper diagnosis.

This could lead to false negative and invalid results or under-quantification for clinical laboratory tests.

BioMerieux recalled the NucliSENS easyMAG Magnetic Silica (MagSil) because of effects on nucleic acids extraction performance in August.

For a list of lot numbers, expiration and distribution dates go here.

BioMerieux said customers should use an extraction internal control which mimics the extracted target (with same nature/structure), and/or external controls as in the instructions and in good laboratory practices to detect any extraction performance issue.

In case of a detected issue, reduce the sample input volume to 200μl, added the firm.

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