Events

Recall of Device Recall BEA (Bile Esculin Agar) with Azide and Vancomycin

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
    71602
  • Event Risk Class
    Class 2
  • Event Number
    Z-2276-2015
  • Event Initiated Date
    2015-06-26
  • Event Date Posted
    2015-07-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138501
  • 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, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
  • Reason
    Hardy diagnostics is recalling macconkey agar with ciprofloxacin, brain heart infusion broth with ciprofloxacin 1 ug, mdr acinetobacter, bea with azide and vancomycin, bea agar with vancomycin, gentamicin, and amphotericin b, bea broth with vancomycin, and vre broth due to lack of 510(k) clearance.
  • Action
    The firm initially called customers to inform them of the recall. The firm's phone script stated that they were discontinung the product and as part of the process were recalling anything that still might be within expiration date. The instructions provided via phone were to discard any remaining plates that are in stock in order for credit. The phone script stated that the firm was going to be sending something in writing. On 06/25-29/15 the firm sent out notification letters to customers to inform them that they were discontuing the product, and were requested anything remaining within expiration to be discarded. The firm requests that customers complete, sign, and fax back the endlosed form stating their compliance with the above action. The notification states if the laboratory was unable to be reached via telephone and would like a credit to contact the Customer Service Department at 800-266-2222, option 1. For any questions the firm states to contact Technical Services Department at 800-266-222, option 2 or via email at TechService@HardyDiagnostics.com. Follow-up calls will be made to customers who do not respond.

Device

Device Recall BEA (Bile Esculin Agar) with Azide and Vancomycin
  • Model / Serial
    Lot number: 15075. 15096, 15107, 15121, 15134, and 15154 Cat no. G103
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. Nationwide Distribution and the country of: Canada
  • Product Description
    Hardy Diagnostics || BEA Agar with Vancomycin || container type: 15x100mm monoplate || packaged: 10 plates/sleeve || Product Usage: || BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vancomycin-resistant enterococci/group D streptococci, such as Enterococcus faecalis and E. faecium, from fecal and rectal cultures.
  • 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