FDA Device recall Z-2409-2018
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic t…
- FDA Device
- Class II
- terminated
- Published 2018-07-18
On 2018-07-18 the FDA classified a Class II recall of Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic t… by Immuno Mycologics, citing potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2409-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-30 |
| Published | 2018-07-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Immuno Mycologics |
| Distribution | n/a |
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
Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results
Identifiers
| code_info | Lot/Serial Numbers: L102802 and L103012 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2409-2018%22
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