FDA Device recall Z-0556-2016
Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women…
- FDA Device
- Class II
- terminated
- Published 2016-01-06
On 2016-01-06 the FDA classified a Class II recall of Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women… by Biomerieux, citing FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0556-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-23 |
| Published | 2016-01-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | CA, GA, IN, MA, MN, MO, NY, OH, PA |
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
FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.
Identifiers
| code_info | REF 42722 - Lot Numbers 896, 897 & 899 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0556-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.