Biomerieux Inc recalls Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalacti…

Recall date

November 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0556-2016

FDA classification

Class II

Brand / firm

Biomerieux Inc

Sold / distributed

US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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