Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to d
FDA device recall Z-2040-2016 · posted 2016-06-20 · Terminated
Recall details
- Recalling firm
- Immuno-Mycologics, Inc
- Reason for recall
- The device was found to have bacterial contamination.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GMJ
- Quantity affected
- 467 units
- Distribution
- Nationwide Distribution to UT, MA, OH, IN, NC, NY, VA, CA, IA and KY.
- Date initiated
- 2016-05-09
- Date posted
- 2016-06-20
- Date terminated
- 2017-01-10
- Location
- Norman, OK
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HISTOPLASMA YEAST ANTI #CF10021X (K791393) | Immuno-Mycologics, Inc. | 1979-08-16 |