Class I — BioMerieux SA
| Recalling firm | BIOMERIEUX SA |
|---|---|
| Registered facility | View this company's 16 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| 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. |
| 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. |
| 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,… |
| Initiated | 2016-11-23 |
| Classified | 2017-01-13 |
| Terminated | 2022-03-10 |
| Recall number | Z-0976-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — BioMerieux SA (Z-0976-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76026/
Alerts for BIOMERIEUX SA
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.