Recall Z-0977-2017— 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: NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG¿ is intended to be used for the extraction of total nucleic acids 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
NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG¿ is intended to be used for the extraction of total nucleic acids 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.