Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.
This recall has been terminated (originally issued December 29, 2015).
- Company
- Biomerieux Inc
- Recall Initiated
- November 23, 2015
- Posted
- December 29, 2015
- Terminated
- February 24, 2016
- Recall Number
- Z-0556-2016
- Quantity
- 24 cartons
- Firm Location
- Hazelwood, MO
- Official Source
- View on FDA website ↗
Reason for Recall
FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.
Distribution
US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.
Lot / Code Info
REF 42722 - Lot Numbers 896, 897 & 899
Root Cause
No Marketing Application
Action Taken
The firm, Biomerieux, sent an "Urgent Product Removal Notice" dated November 23, 2015 to its consignees. The letter described the product, problem and actions to be taken. The consignees were instructed to confirm that the letter has been distributed and reviewed by all appropriate personnel, discontinue and discard any remaining inventory, store letter with your bioMerieux documentation and complete the attached Acknowledgement Form via fax to: (919) 620-3306 attention of: bioMerieux NA ComOps QA/RA. If you have any questions or concerns, please contact your local bioMrieux Clinical Customer Service organization at (800) 682-2666.