Z-2301-2020 Class II Terminated
FDA device recall Z-2301-2020 was initiated by Immuno-Mycologics, Inc on November 4, 2019 and is designated Class II. Reason for recall: False positive results due to potential contamination of reagent. The recall status is terminated (terminated May 27, 2022). Affected quantity: 155 vials.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2020
- Initiation Date
- November 4, 2019
- Termination Date
- May 27, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 155 vials
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.
Distribution Pattern
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.
Code Information
Lot number L106909; UDI # (01) 00816387020391 (17) 220610(10)L106909