Recall Z-0976-2017— BioMerieux SA
Class I · Terminated
Class I FDA medical device recall by BioMerieux SA, initiated 2016-11-23, terminated 2022-03-10. FDA's recall record names no specific 510(k) clearance for this event. Product: MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ system is an in vitro diagnostic medical device and is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens.. Reason: A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). This is the same issue as in recall Z-2342-2016..
- Recalling firm
- BioMerieux SA
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2016-11-23
- Terminated
- 2022-03-10
- Firm location
- Marcy L'Etoile, France
Product description
MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ system is an in vitro diagnostic medical device and is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens.
Reason for recall
A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). This is the same issue as in recall Z-2342-2016.
Data sourced from openFDA. This site is unofficial and independent of the FDA.