FDA Device recall Z-1109-2017
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
- FDA Device
- Class II
- terminated
- Published 2017-02-08
On 2017-02-08 the FDA classified a Class II recall of Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003 by Immuno Mycologics, citing 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 rep….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1109-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-27 |
| Published | 2017-02-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Immuno Mycologics |
| Distribution | US |
Product
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
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.
Identifiers
| code_info | 161028133653JH, 161003111544KH, and 161007105036JG |
|---|
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-1109-2017%22
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