Class II — Biomerieux Inc
| 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 | FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States. |
| Product | Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens. |
| Quantity | 24 cartons |
| Distribution | US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA. |
| Initiated | 2015-11-23 |
| Classified | 2015-12-29 |
| Terminated | 2016-02-24 |
| Recall number | Z-0556-2016 |
| 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 Inc (Z-0556-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72760/
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