Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactia

FDA device recall Z-0556-2016 · posted 2015-12-29 · Terminated

Recall details

Recalling firm

Biomerieux Inc

Reason for recall

FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.

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.

Root cause

No Marketing Application

Status

Terminated

Product code

NJR

Quantity affected

24 cartons

Distribution

US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.

Date initiated

2015-11-23

Date posted

2015-12-29

Date terminated

2016-02-24

Location

Hazelwood, MO