Granada Biphasic Broth The product is a selective medium for the… — Class II medical device recall Z-0556-2016
Terminated recall by Biomerieux Inc, reported 2016-01-06, distributed in CA, GA, IN, MA, MN, MO, NY, OH…. FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United
| Recall number | Z-0556-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2015-11-23 |
| Classified | 2015-12-29 |
| Reported by FDA | 2016-01-06 |
| Terminated | 2016-02-24 |
| Distributed | CA, GA, IN, MA, MN, MO, NY, OH, PA |
| Quantity | 24 cartons |
| Lot numbers | 896, 897, 899 |
| Model numbers | 42722 |
Product
Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.
Reason for recall
FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0556-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.