Drug recall
Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus…
FDA recall event 72760 · Class II · Biomerieux Inc
Key facts
| Event ID | 72760 |
|---|---|
| Recall numbers | Z-0556-2016 |
| Recalling firm | Biomerieux Inc |
| Product type | Devices |
| Products | Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States. |
| Initiation date | Nov 23, 2015 |
| Report date | Jan 6, 2016 |
| Termination date | Feb 24, 2016 |
| City | Hazelwood |
| State | MO |
| Country | United States |
| FEI number | 1950204 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: