Class 2 Device Recall Histoplasma Immunodiffusion (ID) Antigen

• Date Initiated by Firm: November 04, 2019
• Create Date: June 09, 2020
• Recall Status: Terminated on May 27, 2022
• Recall Number: Z-2301-2020
• Recall Event ID: 85368
• 510(K)Number: K830837
• Product Classification: Antigens, histoplasma capsulatum, all - Product Code GMJ
• Product: Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen
• Code Information: Lot number L106909; UDI # (01) 00816387020391 (17) 220610(10)L106909
• Recalling Firm/ Manufacturer: Immuno-Mycologics, Inc; 2700 Technology Pl; Norman OK 73071-1127
• For Additional Information Contact: Joy Pelfrey; 405-360-4669
• Manufacturer Reason for Recall: False positive results due to potential contamination of reagent.
• FDA Determined Cause: Under Investigation by firm
• Action: On November 04, 2019, the firm sent out an urgent medical device recall notification to customers via e-mail of voluntary recall of an antigen, due to false positive results. The antigen was distributed to customers between September 4, 2019 and October 14, 2019. 1 complaint associated with this issue was reported. There have been no reports of patient injury or death. Risk to Health: The firm reported that in the case of false-positives, clinicians who use immuno-diffusion (ID) results alone may unnecessarily treat patients. The results of any sample that ran negative using this lot of antigen should NOT be affected. In other words, the negative predictive value of this lot has not changed from previous lots. If the test is interpreted without considering other clinical evidence, it is not possible to tell if a positive result is a true positive or a false positive. The firm notified customers to : Immediately check inventory and destroy the antigen and immediately complete the attached Acknowledgement and Receipt Form and attach it to an email and send the completed form to manufacturer using Email or mail to: Joy Pelfrey IMMY 2701 Corporate Centre Dr Norman, OK 73069 Additionally, the firm instructed customers to inform staff members of this recall, including to relevant clinicians, any other organization and display the recall notice. The customers can request a free-of-charge replacement. The actions being taken by the recalling firm is that they are immediately removing all material from the market and will be investigating the source for false-positive results. The firm will take mitigation actions.
• Quantity in Commerce: 155 vials
• Distribution: Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, FL, IL, IN, MI, MN, NY,TX, UT, VA, WI and the countries of France, Spain, Hong Kong, United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GMJ and Original Applicant = IMMUNO-MYCOLOGICS, INC.