FDAFDA · Food and drugs·Recall number Z-0556-2016
Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.
Published January 6, 2016 · Recall initiated: November 23, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomerieux Inc
- Distributor
- US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.
- Lot
- REF 42722 - Lot Numbers 896, 897 & 899
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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