Events

Recall of Device Recall HardyCHROM SS Agar

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
    70767
  • Event Risk Class
    Class 2
  • Event Number
    Z-1444-2015
  • Event Initiated Date
    2015-03-04
  • Event Date Posted
    2015-04-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134635
  • 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, selective and differential - Product Code JSI
  • Reason
    The firm is recalling hardychrom ss, cat. no. g327 lot no. 15037 due to a report of possible lack of color development in shigella organisms in the referenced lot.
  • Action
    On 03/12/2015 the firm sent recall notification letters to customers. The firm's letter informs customers of the reason for recall, and requests that they discard any remaining stock of the recalled lot. The firm continues to request that even though the customer has been informed of the necessary actions that they still take a moment to complete, sign, and fax back the enclosed form stating their compliance with the above action to the attention of their Quality Assurance Department at (805) 614-9274. The firm stated that the form is required for their records and need to document the full quantity received, used and/or discarded. For replacements or credit to please contact the Customer Service Department at (800) 266-2222 and select option 1. The firm states that replacements will be sent out at no charge to customers, or a credit will be applied to the invoice. For any additional questions the firm states to contact Technical Services at (800) 266-2222, option 2 or e-mail at techservice@hardydiagnostics.com.

Device

Device Recall HardyCHROM SS Agar
  • Model / Serial
    Lot no. 15037, Expires: 00-00-2000
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- U.S., including the states of TX, CA, AZ, WA, PR, and IA; and the countries of Canada and NSW.
  • Product Description
    Hardy Diagnostics cat no. G327 HardyCHROM SS Agar || (HardyCHROM Salmonella Shigella) || Cat no: G327 || Container type: 15x100mm monoplate || Packaged: 10 plates/sleeve || Storage: 2 to 8 degrees C. on receipt in dark || A selective chromogenic medium for the primary screening isolation, and differentiation of Salmonella & Shigella spp.
  • 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