Cryptococcal Antigen Lateral Flow Assay — Class II medical device recall Z-1109-2017
Terminated recall by Immuno-Mycologics, Inc, reported 2017-02-08, distributed nationwide. The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99
| Recall number | Z-1109-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Immuno-Mycologics, Inc, Norman, OK, United States |
| Recall initiated | 2016-12-27 |
| Classified | 2017-01-27 |
| Reported by FDA | 2017-02-08 |
| Terminated | 2017-03-08 |
| Distributed | Nationwide (US) |
| Quantity | 630 units |
Product
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1109-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.