Class I Recall of bioMerieux NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents
BioMerieux is recalling the NucliSENS® easyMAG® Magnetic Silica (MagSil) because of effects on nucleic acids extraction performance. MagSil is used to extract and purify genetic material from patient samples. Kits with the affected lots of the Magnetic silica have exhibited a decrease of extraction performance with certain downstream applications. The detection problem could lead to a risk of false negative or invalid results for clinical laboratory tests. The use of the affected product may cause serious adverse health consequences, including death.
According to the FDA, the following groups may be affected by this recall:
- Laboratories who utilize the NucliSENS® easyMAG® nucleic acid extraction system as part of diagnostic applications.
- Health care providers who utilize laboratories who use the NucliSENS® easyMAG® nucleic acid extraction system as part of diagnostic applications.
- All patient groups receiving a diagnosis using laboratories that utilize the NucliSENS® easyMAG nucleic acid extraction system as part of diagnostic applications.
On July 18, 2016 and on August 10, 2016, bioMerieux sent Urgent Product Safety Correction Notices to affected customers. Please follow the company’s second correction notice dated August 10, 2016 for detailed instructions. The notice asked customers to:
- Reduce the sample input volume to 200μl
- Note: If using bioMerieux downstream applications (PCR/RT-PCR ARGENE) and NucliSENS easyQ HIV 1 v2.0 (NASBA technology), the sample input should be in accordance with the intended for use (IFU) claims for the assay and should be no greater than 400μl.
- The laboratory must verify that the expected performance is not affected by the extraction reagents.
- Use an internal extraction control which mimics the target sample (with same nature/structure/volume/matrix) or is designed to detect decreased assay performance (including the extraction process), and/or external controls as recommended in the instructions for use and as required by US regulation to detect any extraction performance issue.
- Do not use for single-stranded RNA virus applications if the RNA is extracted without a matrix (i.e. in water).
- Please review all results that were generated with the affected lots of extraction reagent to determine the appropriate course of action.
- If you observe any issues with extraction or assay performance, contact your local customer service representative.
- Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred this product.
Further – the FDA announced a continuation of this Class I Recall identifying additional affected product lots, and an additional product, the NucliSENS Magnetic Extraction Reagents, which have been determined to be in scope of the previous recall. A link to the details of the additional recall details is provided below.
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