Z-0470-2016Class II

FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the...

Name: Z-0470-2016 FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the...
Creator: Hardy Diagnostics
Published: 2015-11-18
License: https://open.fda.gov/license/

Hardy Diagnostics / initiated 2015-11-18 / Terminated

FDA source

Hardy Diagnostics began a recall of FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus... on 2015-11-18. FDA classified it as Class II and gives the reason as "The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0470-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-18
Posted: 2015-12-23
Terminated: 2016-03-28
Recalling firm: Hardy Diagnostics
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.
Product code: JSC Culture Media, General Nutrient Broth
Reason for recall: The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.
FDA root cause: Under Investigation by firm
Action: Hardy Diagnostic notified Customers via phone on November 18, 2015, followed up with written notifications being sent via first class, email, or facsimile. Customers were instructed to destroy the recalled product according to local regulations for nonhazardous waste if uninoculated or as medical waste if inoculated. and to discard any remaining tubes of the recalled lot. Any remaining product on hand the firm stated would be replaced. The firm stated to customers that they would follow-up the phone conversation with written communication and requested a full name, and email or fax number. We sincerely apologize for the inconvenience. Thank you in advance for completing the attached form. Please feel free to contact our Technical Services Department if you have not received your replacements or if you have additional questions about this notification. Technical Services can be reached at (800) 266-2222, option 2 or via email at [email protected].
Quantity in commerce: 500 25pk/20)
Distribution: US. Distribution to the states of : CA, WI, MD and UT. .
Product codes and lots: Cat. no. K31 Lot no.15231

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0470-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0470-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-23

Product code JSC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)