Device product
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.
Z-0470-2016
Product summary
- Event
- Event 72786
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 25pk/20)
- Official record key
device-enforcement:Z-0470-2016
Official wording
Reason: The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.
Code information: Cat. no. K31 Lot no.15231
Distribution pattern: US. Distribution to the states of : CA, WI, MD and UT. .
Derived failure modes
-
Microbial contamination
Burkholderia fungorum contamination