Events

Recall of Device Recall Cryptococcal Antigen Lateral Flow Assay (CrAg LFA)

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
    76159
  • Event Risk Class
    Class 2
  • Event Number
    Z-1109-2017
  • Event Initiated Date
    2016-12-27
  • Event Date Posted
    2017-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152413
  • 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
    Antisera, latex agglutination, cryptococcus neoformans - Product Code GMD
  • Reason
    The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. the recalling firm is aware of three customers who reported false positive results.
  • Action
    Immuno sent an Urgent: Medical Device Recall Letter dated December 27, 2016, to all affected customers. All customers were notified via emails to stop using the product on December 27th and December 28th. A recall notification and response form was attached to the email. For further questions, please call (405)364-1058.

Device

Device Recall Cryptococcal Antigen Lateral Flow Assay (CrAg LFA)
  • Model / Serial
    161028133653JH, 161003111544KH, and 161007105036JG
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide throughout the US
  • Product Description
    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
  • 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