Recall Z-1109-2017 ยท GMD Antisera, Latex Agglutination, Cryptococcus Neoformans
Immuno-Mycologics, Inc
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
| Date | Jan 27, 2017 (initiated Dec 27, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Material/Component Contamination |
| Action | 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. |
| Quantity | 630 units |
| Distribution | Nationwide throughout the US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112422 | CRAG LATERAL FLOW ASSAY (LFA) Immuno-Mycologics, Inc., Mar 28, 2012 |