Class II — 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 II |
| Status | Terminated |
| Reason | Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product. |
| Product | NucliSENS® Magnetic Extraction Reagents |
| Quantity | 42 units |
| Distribution | Nationwide distribution to MD, TX, MA, GA, OH, OR, CA, and WA. |
| Initiated | 2018-09-17 |
| Classified | 2018-10-23 |
| Terminated | 2020-05-18 |
| Recall number | Z-0218-2019 |
| 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 II recall — BioMerieux SA (Z-0218-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81067/
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