Device 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
Z-2301-2020
Product summary
- Event
- Event 85368
- Status
- Terminated
- Classification
- Class II
- Quantity
- 155 vials
- Official record key
device-enforcement:Z-2301-2020
Official wording
Reason: False positive results due to potential contamination of reagent.
Code information: Lot number L106909; UDI # (01) 00816387020391 (17) 220610(10)L106909
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.
Derived failure modes
-
Unknown
False positive results due to potential contamination of reagent.