Immuno-Mycologics, Inc 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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

False positive results due to potential contamination of reagent.

Recommended Action

Per FDA guidance

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.