Events

Recall of Device Recall FB Broth

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hardy Diagnostics.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72786
  • Event Risk Class
    Class 2
  • Event Number
    Z-0470-2016
  • Event Initiated Date
    2015-11-18
  • Event Date Posted
    2015-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142209
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Culture media, general nutrient broth - Product Code JSC
  • Reason
    The firm is recalling fb broth cat. no. k31, lot no. 15231 because of potential burkholderia fungorum contamination.
  • 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 TechService@HardyDiagnostics.com.

Device

Device Recall FB Broth
  • Model / Serial
    Cat. no. K31 Lot no.15231
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US. Distribution to the states of : CA, WI, MD and UT. .
  • Product Description
    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.
  • Manufacturer
    Hardy Diagnostics

Manufacturer

Hardy Diagnostics
  • Manufacturer Address
    Hardy Diagnostics, 1430 W McCoy Ln, Santa Maria CA 93455-1005
  • Manufacturer Parent Company (2017)
    Hardy Diagnostics
  • Source
    USFDA