Device product
Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens.
Z-0606-2018
Product summary
- Event
- Event 78731
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10/1 mL vials
- Official record key
device-enforcement:Z-0606-2018
Official wording
Reason: The firm information that the product was reporting false positive results
Code information: Lot # 5072543 Exp Date 03/12/2021; UDI : 10634853000039.
Distribution pattern: Distributed to the states of AL, AZ & MS.
Derived failure modes
-
Unknown
The firm information that the product was reporting false positive results