FDA Device recall Z-0545-2022
CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, I…
- FDA Device
- Class II
- terminated
- Published 2022-02-09
On 2022-02-09 the FDA classified a Class II recall of CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, I… by Immuno Mycologics, citing 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 sm….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0545-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-03 |
| Published | 2022-02-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Immuno Mycologics |
| Distribution | US |
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
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.
Identifiers
| code_info | F1021035 and F1021036 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0545-2022%22
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