Z-2301-2020 Class II Terminated
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