# FDA recall Z-0545-2022

> **Immuno-Mycologics, Inc** · Class II · device recall initiated 2022-01-03.

## 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.

## Distribution

US Nationwide distribution in the states of  AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA.

## Key facts

- **Recall number:** Z-0545-2022
- **Recalling firm:** Immuno-Mycologics, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-01-03
- **Report date:** 2022-02-09
- **Termination date:** 2024-05-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Norman, OK, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0545-2022

## Citation

> AI Analytics. FDA recall Z-0545-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0545-2022. Source: US FDA. Licensed CC0.

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