Z-2301-2020Class II

Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal...

Name: Z-2301-2020 Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal...
Creator: Immuno-Mycologics, Inc
Published: 2019-11-04
License: https://open.fda.gov/license/

IMMY, Inc. / initiated 2019-11-04 / Terminated

FDA source

Immuno-Mycologics, Inc began a recall of Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and... on 2019-11-04. FDA classified it as Class II and gives the reason as "False positive results due to potential contamination of reagent". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2301-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-04
Posted: 2020-06-09
Terminated: 2022-05-27
Recalling firm: IMMY, Inc.
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
Product code: GMJ Antigens, Histoplasma Capsulatum, All
Reason for recall: False positive results due to potential contamination of reagent.
FDA root 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.
Product codes and lots: Lot number L106909; UDI # (01) 00816387020391 (17) 220610(10)L106909

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2301-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2301-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09

Product code GMJ

K830837Class IILa-Histo Antibody System #Hl 1001Immuno-Mycologics, Inc. / cleared 1983-05-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)