Recall Z-2342-2016— BioMerieux SA
Class I · Terminated
Class I FDA medical device recall by BioMerieux SA, initiated 2016-07-08, terminated 2022-03-10. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform..
- Recalling firm
- BioMerieux SA
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2016-07-08
- Terminated
- 2022-03-10
- Firm location
- Marcy L'Etoile, France
Product description
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.
Reason for recall
Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform.
Data sourced from openFDA. This site is unofficial and independent of the FDA.