FDA Device recall Z-0470-2016
FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria sp…
- FDA Device
- Class II
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class II recall of FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria sp… by Hardy Diagnostics, citing the firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0470-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-18 |
| Published | 2015-12-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Hardy Diagnostics |
| Distribution | CA, MD, UT, WI |
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.
Reason
The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.
Identifiers
| code_info | Cat. no. K31 Lot no.15231 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0470-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.