Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
FDA device recall Z-1109-2017 · posted 2017-01-27 · Terminated
Recall details
- Recalling firm
- Immuno-Mycologics, Inc
- Reason for recall
- The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who reported false positive results.
- Action taken
- Immuno sent an Urgent: Medical Device Recall Letter dated December 27, 2016, to all affected customers. All customers were notified via emails to stop using the product on December 27th and December 28th. A recall notification and response form was attached to the email. For further questions, please call (405)364-1058.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- GMD
- Quantity affected
- 630 units
- Distribution
- Nationwide throughout the US
- Date initiated
- 2016-12-27
- Date posted
- 2017-01-27
- Date terminated
- 2017-03-08
- 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 |
|---|---|---|
| CRAG LATERAL FLOW ASSAY (LFA) (K112422) | Immuno-Mycologics, Inc. | 2012-03-28 |