NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG is intended to be
FDA device recall Z-0977-2017 · posted 2017-01-13 · Terminated
Recall details
- Recalling firm
- BioMerieux SA
- 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.
- Action taken
- Consignees were notified via, URGENT PRODUCT SAFETY CORRECTION NOTICE on/about 11/23/2016. This is the same issue as in recall Z-2342-2016, notification letter sent on/about 7/8/2016.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- PPM
- Quantity affected
- 3723 units in total
- Distribution
- Worldwide distribution. US Nationwide; BioMerieux Subsidiaries in: Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech republic, Germany, Spain, France United Kingdom, G
- Date initiated
- 2016-11-23
- Date posted
- 2017-01-13
- Date terminated
- 2022-03-10
- Location
- Marcy L'Etoile, France
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