Recall Z-0556-2016 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Biomerieux Inc
Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.
| Date | Dec 29, 2015 (initiated Nov 23, 2015) |
| Status | Terminated |
| Reason | FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States. |
| Root cause | 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 bioMrieux Clinical Customer |
| Quantity | 24 cartons |
| Distribution | US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.