FDA recall Z-2301-2020

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

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

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