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
This recall has been terminated (originally issued June 20, 2016).
- Company
- Immuno-Mycologics, Inc
- Recall Initiated
- May 9, 2016
- Posted
- June 20, 2016
- Terminated
- January 10, 2017
- Recall Number
- Z-2040-2016
- Quantity
- 467 units
- Firm Location
- Norman, OK
- Official Source
- View on FDA website ↗
Reason for Recall
The device was found to have bacterial contamination.
Distribution
Nationwide Distribution to UT, MA, OH, IN, NC, NY, VA, CA, IA and KY.
Lot / Code Info
Lot 111WH3
Root Cause
Process control
Action Taken
Immuno-Mycologics, Inc sent an Urgent Medical Device Recall letter dated May 9, 2016, to all affected customers. The letter identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their stock and destroy affected stock on hand. Immediately complete the attached Acknowledgement and Receipt Form even if they do not have affected stock. Customers who require replacement indicate the number of vials needed in the attached Acknowledgement Form. Customers with questions were instructed to call 1-405-360-4669.