Exact FDA event identifier

Event 72786

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: November 18, 2015
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Hardy Diagnostics

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Recall number: Z-0470-2016
Initiated: November 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: Hardy Diagnostics
Quantity: 500 25pk/20)

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0

Burkholderia fungorum contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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. .