Hardy Diagnostics: Medical Device Recall in 2015 - (Recall #: Z-0470-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 18, 2015

Date Posted: December 30, 2015

Recall Number: Z-0470-2016

Event ID: 72786

Reason for Recall:

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

Status: Terminated

Product Quantity: 500 25pk/20)

Code Information:

Cat. no. K31 Lot no.15231

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated