# FDA recall Z-2301-2020

> **Immuno-Mycologics, Inc** · Class II · device recall initiated 2019-11-04.

## 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

## Reason for recall

False positive results due to potential contamination of reagent.

## 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.

## Key facts

- **Recall number:** Z-2301-2020
- **Recalling firm:** Immuno-Mycologics, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-04
- **Report date:** 2020-06-17
- **Termination date:** 2022-05-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Norman, OK, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2301-2020

## Citation

> AI Analytics. FDA recall Z-2301-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2301-2020. Source: US FDA. Licensed CC0.

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