Cryptococcal Antigen Lateral Flow Assay — Class II medical device recall Z-2409-2018
Terminated recall by Immuno-Mycologics, Inc, reported 2018-07-18. Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results
| Recall number | Z-2409-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Immuno-Mycologics, Inc, Norman, OK, United States |
| Recall initiated | 2018-03-30 |
| Classified | 2018-07-10 |
| Reported by FDA | 2018-07-18 |
| Terminated | 2020-05-21 |
| Quantity | 875 units |
| Serial numbers | L102802, L103012 |
| Model numbers | CR2003 |
Product
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebral spinal fluid (CSF). The CrAg Lateral Flow Assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis.
Reason for recall
Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test 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-2409-2018. 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.