Device product
Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosis
Z-2040-2016
Product summary
- Event
- Event 74113
- Status
- Terminated
- Classification
- Class II
- Quantity
- 467 units
- Official record key
device-enforcement:Z-2040-2016
Official wording
Reason: The device was found to have bacterial contamination.
Code information: Lot 111WH3
Distribution pattern: Nationwide Distribution to UT, MA, OH, IN, NC, NY, VA, CA, IA and KY.
Derived failure modes
-
Microbial contamination
bacterial contamination