CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY — Class II medical device recall Z-0545-2022
Terminated recall by Immuno-Mycologics, Inc, reported 2022-02-09, distributed nationwide. The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to ha
| Recall number | Z-0545-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Immuno-Mycologics, Inc, Norman, OK, United States |
| Recall initiated | 2022-01-03 |
| Classified | 2022-01-31 |
| Reported by FDA | 2022-02-09 |
| Terminated | 2024-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 411 kits |
| Reason classes | microbial contamination |
| Pathogens | mold |
| UPC / GTIN / UDI-DI | 00816387020919 |
| Model numbers | CR2003 |
Product
CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919
Reason for recall
The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to have reduced specificity (90% now versus 99% before). As a result, a small number of samples with positive test results may be false positives, which may cause some patients to initiate unnecessary anti-fungal therapy. Samples with negative test results are NOT affected.
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-0545-2022. 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.