Recall Z-2040-2016 ยท GMJ Antigens, Histoplasma Capsulatum, All
Immuno-Mycologics, Inc
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
| Date | Jun 20, 2016 (initiated May 9, 2016) |
| Status | Terminated |
| Reason | The device was found to have bacterial contamination. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 467 units |
| Distribution | Nationwide Distribution to UT, MA, OH, IN, NC, NY, VA, CA, IA and KY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K791393 | HISTOPLASMA YEAST ANTI #CF10021X Immuno-Mycologics, Inc., Aug 16, 1979 |