FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0556-2016
- Recalling firm
- Biomerieux Inc
- Product
- Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.
- Status
- Terminated
- Initiated
- 2015-11-23
- Posted
- 2015-12-29
- Terminated
- 2016-02-24
- 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 Service organization at (800) 682-2666.
- Quantity
- 24 cartons
- Distribution
- US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.
- Lot, serial or model codes
- REF 42722 - Lot Numbers 896, 897 & 899
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NJR
- Firm FEI
- 1950204
- Firm city
- Hazelwood
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28