Hardy Diagnostics recalls FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultiva…

Recall date

November 18, 2015

Source

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

Recall number

Z-0470-2016

FDA classification

Class II

Brand / firm

Hardy Diagnostics

Sold / distributed

US. Distribution to the states of : CA, WI, MD and UT. .

Why it was recalled

The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.

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

What was recalled

FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens.