PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 30, 2015 Initiated: November 18, 2015 #Z-0470-2016

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.

Reason for Recall

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

Details

Recalling Firm
Hardy Diagnostics
Units Affected
500 25pk/20)
Distribution
US. Distribution to the states of : CA, WI, MD and UT. .
Location
Santa Maria, CA

Frequently Asked Questions

What product 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.. Recalled by Hardy Diagnostics. Units affected: 500 25pk/20).
Why was this product recalled?
The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 30, 2015. Severity: Moderate. Recall number: Z-0470-2016.