FB Broth — Class II medical device recall Z-0470-2016
Terminated recall by Hardy Diagnostics, reported 2015-12-30, distributed in CA, MD, UT, WI. The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamin
| Recall number | Z-0470-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hardy Diagnostics, Santa Maria, CA, United States |
| Recall initiated | 2015-11-18 |
| Classified | 2015-12-23 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2016-03-28 |
| Distributed | CA, MD, UT, WI |
| Pathogens | burkholderia |
| Lot numbers | 15231, 15231A |
| Model numbers | K31 |
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 for recall
The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0470-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.