Z-0556-2016 Class II Terminated
FDA device recall Z-0556-2016 was initiated by Biomerieux Inc on Nov 23, 2015 and is designated Class II. Reason for recall: FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States. The recall status is terminated (terminated Feb 24, 2016). Affected quantity: 24 cartons.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 6, 2016
- Initiation Date
- Nov 23, 2015
- Termination Date
- Feb 24, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 cartons
Product Description
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.
Distribution Pattern
US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.
Code Information
REF 42722 - Lot Numbers 896, 897 & 899
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0556-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026