Recall Z-2301-2020— Immuno-Mycologics, Inc

Name: FDA recall Z-2301-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-04

Class II · Terminated

Class II FDA medical device recall by Immuno-Mycologics, Inc, initiated 2019-11-04, terminated 2022-05-27. It names one FDA 510(k) clearance: K830837. 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: False positive results due to potential contamination of reagent..

Recalling firm: Immuno-Mycologics, Inc
Classification: Class II
Status: Terminated
Initiated: 2019-11-04
Terminated: 2022-05-27
Firm location: Norman, OK, United States

510(k) clearances named in this recall

1 on FDA's record

K830837 — LA-HISTO ANTIBODY SYSTEM #HL 1001Immuno-Mycologics, Inc.·cleared 1983-05-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.