Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.
FDA Recall Z-0556-2016 · Posted 2015-12-29
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Recalling FirmBiomerieux Inc
Recall StatusTerminated
Product CodeNJR
Date Initiated2015-11-23
Date Terminated2016-02-24
Product Quantity24 cartons
Reason for Recall
FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.
Firm Action
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.
Root Cause
No Marketing Application
Distribution Pattern
US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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