Events

Recall of Device Recall GBS Detect

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
    73688
  • Event Risk Class
    Class 2
  • Event Number
    Z-1571-2016
  • Event Initiated Date
    2016-03-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144758
  • 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 non-differential - Product Code JSJ
  • Reason
    Performance failure; poor hemolytic reaction of non or weakly hemolytic group b streptococcus (gbs) with the target qc organism, streptococcus agalactiae (atcc 13813) due to product deterioration.
  • Action
    On 03/21/2016 customers were notified by phone, and were sent a notification letter. Customers were instructed via phone call to discard remaining plates of the implicated lot, and to notify the firm of how many plates are left. The firm stated that they will be issuing replacements. The firm stated that they will be sending written notification as well. The firm requested full name and e-mail or fax number in order to follow-up with the written notification. The customer notification letter instructs customers to complete, sign, scan/e-mail or fax back enclosed form stating compliance with the action regarding the specific lot. The firm requests the form be returned to the attention of the Quality Assurance Department at techservice@hardydiagnostics.com, fax number 805-614-9274. If the lab is unable to be reached via telephone and would like replacements or credit contact Customer Service Department at 800-266-2222, option 1. Replacements will be sent out at no charge. Any questions contact Technical Services Department at 800-266-2222, option 2 or via e-mail at techservice@hardydiagnostics.com.

Device

Device Recall GBS Detect
  • Model / Serial
    Lot H16054 and H15056.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    U.S. Distribution to the following states: AL, SC, FL, CT, VA, WI, MA, MI, WV, OH, IN, IL, NC, and TX.
  • Product Description
    Hardy Diagnostics GBS Detect || Cat no. A300. || Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
  • 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