Recalls / —
—#142164
Product
Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.
- FDA product code
- NJR — Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
- Device class
- Class 1
- Medical specialty
- Microbiology
- Affected lot / code info
- REF 42722 - Lot Numbers 896, 897 & 899
Why it was recalled
FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.
Root cause (FDA determination)
No Marketing Application
Action the firm took
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.
Recalling firm
- Firm
- Biomerieux Inc
- Address
- 595 Anglum Rd, Hazelwood, Missouri 63042-2320
Distribution
- Distribution pattern
- US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.
Timeline
- Recall initiated
- 2015-11-23
- Posted by FDA
- 2015-12-29
- Terminated
- 2016-02-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #142164. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.