Z-0470-2016 Class II Terminated

Recalled by Hardy Diagnostics — Santa Maria, CA

Recall Details

Product Type
Devices
Report Date
December 30, 2015
Initiation Date
November 18, 2015
Termination Date
March 28, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
500 25pk/20)

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.

Distribution Pattern

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

Code Information

Cat. no. K31 Lot no.15231