Reported Aug 17, 2016 · Terminated
NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with…
BioMerieux SA
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BioMerieux SA · Chemin De L'Orme · Marcy L'Etoile · N/A
Is this the product you have?
- NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extraction systems which mention these products in their User Manuals. They enable the automated extraction (purification and concentration) of total nucleic acids (RNA/DNA) from biological samples which are liquid and homogeneous. These products are intended for in vitro diagnostic use by healthcare professionals only.
- Lot codes and dates
Lots - Z017BB1MSZ017BF1MSZ017CA1MSZ017BE1MSZ017CC1MSZ017CD1MSZ017CH1MSZ017BD1MSZ017DB1MSZ017BA1MSZ017CF1MSZ017CE1MSZ017CG1MSZ017DA1MSZ017DC1MSZ017DD1MSZ017EA1MSZ017EB1MSZ017FB1MSZ017KF1MSZ017KG1MSZ017KH1MS
- Amount recalled
- 7,845 units
Where it was sold
Why it was recalled
Stop using this product now
Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform.
Using this product could cause serious injury, illness or death — stop using it now.
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