Recall Z-0556-2016— Biomerieux Inc

Name: FDA recall Z-0556-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-23

Class II · Terminated

Class II FDA medical device recall by Biomerieux Inc, initiated 2015-11-23, terminated 2016-02-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.. Reason: FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States..

Recalling firm: Biomerieux Inc
Classification: Class II
Status: Terminated
Initiated: 2015-11-23
Terminated: 2016-02-24
Firm location: Hazelwood, MO, United States

Product description

Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.

Reason for recall

FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.

Data sourced from openFDA. This site is unofficial and independent of the FDA.