FDA Medical Device Recalls (openFDA)
BioMerieux SA: 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.
- Recall number
- Z-0977-2017
- Recalling firm
- BioMerieux SA
- 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.
- Status
- Terminated
- Initiated
- 2016-11-23
- Posted
- 2017-01-13
- Terminated
- 2022-03-10
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 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, Greece, China, Hungary, India, Italy, Japan, South Korea, Netherlands, Poland, Portugal, Russia Fed., Sweden, Singapore, Thailand, Turkey, South Africa; Distributors in: Peru, Kenya, Morocco, Serbia, Romania, Uruguay, Latvia, Dutch Antilles, Israel, Georgia, Armenia, Malaysia, Belarus and Direct Customers in: Togo, Djibouti, Burkina Faso, Mongolia, Zimbabwe, Uganda and Iraq.
- Lot, serial or model codes
- Reference number: 200293, Lot number: 16072701.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PPM
- Firm FEI
- 1000611339
- Firm city
- Marcy L'Etoile
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28