CLASS II Device recall · Reported 30 Dec 2015 · FDA Enforcement Report

FB Broth (Fastidious Bacteria Broth) recalled by Hardy Diagnostics

Hardy Diagnostics is recalling FB Broth (Fastidious Bacteria Broth), distributed in California, Maryland, Utah, Wisconsin. The recall was initiated on 18 Nov 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCat. no. K31 Lot no.15231

Quantity recalled500 25pk/20)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0470-2016
FDA event ID: 72786
Recalling firm: Hardy Diagnostics, Santa Maria, CA
Classification: Class II
Status: Terminated
Recall initiated: 18 Nov 2015
FDA classified: 23 Dec 2015
Reported: 30 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Sterility
Device type: Other Medical Devices

Timeline

18 Nov 2015	Recall initiated by company
23 Dec 2015	Classified by FDA	+35 days
30 Dec 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

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

California Maryland Utah Wisconsin

Questions about this recall

Is FB Broth (Fastidious Bacteria Broth) recalled?

Yes. Hardy Diagnostics recalled FB Broth (Fastidious Bacteria Broth) on 18 Nov 2015. The recall is Class II and its status is Terminated. Recall number Z-0470-2016.

Why was it recalled?

The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.

Which lots are affected?

Cat. no. K31 Lot no.15231

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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