Z-0556-2016Class II

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

Name: Z-0556-2016 Granada Biphasic Broth The product is a selective medium for the screening and identification of...
Creator: Biomerieux Inc
Published: 2015-11-23
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2015-11-23 / Terminated

FDA source

Biomerieux Inc began a recall of Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical... on 2015-11-23. FDA classified it as Class II and gives the reason as "FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0556-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-23
Posted: 2015-12-29
Terminated: 2016-02-24
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.
Product code: NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Reason for recall: FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.
FDA 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 in commerce: 24 cartons
Distribution: US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.
Product codes and lots: REF 42722 - Lot Numbers 896, 897 & 899

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0556-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0556-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-06	2015-12-29

Product code NJR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)