Events

Recall of Device Recall Histoplasma Yeast Complement Fixation Antigen Dilute

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Immuno-Mycologics, Inc.

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
    74113
  • Event Risk Class
    Class 2
  • Event Number
    Z-2040-2016
  • Event Initiated Date
    2016-05-09
  • Event Date Posted
    2016-06-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146320
  • 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
    Antigens, histoplasma capsulatum, all - Product Code GMJ
  • Reason
    The device was found to have bacterial contamination.
  • Action
    Immuno-Mycologics, Inc sent an Urgent Medical Device Recall letter dated May 9, 2016, to all affected customers. The letter identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their stock and destroy affected stock on hand. Immediately complete the attached Acknowledgement and Receipt Form even if they do not have affected stock. Customers who require replacement indicate the number of vials needed in the attached Acknowledgement Form. Customers with questions were instructed to call 1-405-360-4669.

Device

Device Recall Histoplasma Yeast Complement Fixation Antigen Dilute
  • Model / Serial
    Lot 111WH3
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to UT, MA, OH, IN, NC, NY, VA, CA, IA and KY.
  • Product Description
    Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 || The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosis
  • Manufacturer
    Immuno-Mycologics, Inc

Manufacturer

Immuno-Mycologics, Inc
  • Manufacturer Address
    Immuno-Mycologics, Inc, 2700 Technology Pl, Norman OK 73071-1127
  • Manufacturer Parent Company (2017)
    Immuno-Mycologics Inc.
  • Source
    USFDA