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U.S. Department of Health and Human Services

Class 2 Device Recall Granada Biphasic Broth

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  Class 2 Device Recall Granada Biphasic Broth see related information
Date Initiated by Firm November 23, 2015
Date Posted December 29, 2015
Recall Status1 Terminated 3 on February 24, 2016
Recall Number Z-0556-2016
Recall Event ID 72760
Product Classification selective medium for the screening and identification - Product Code NJR
Product Granada Biphasic Broth

The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.
Code Information REF 42722 - Lot Numbers 896, 897 & 899
Recalling Firm/
Manufacturer		 Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
For Additional Information Contact Jeff Scanlan
314-731-8694
Manufacturer Reason
for Recall		 FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.
FDA Determined
Cause 2		 No Marketing Application
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 bioM¿rieux Clinical Customer Service organization at (800) 682-2666.
Quantity in Commerce 24 cartons
Distribution US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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