Immuno-Mycologics, Inc: Medical Device Recall in 2022 - (Recall #: Z-0545-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 3, 2022

Date Posted: February 9, 2022

Recall Number: Z-0545-2022

Event ID: 89370

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.

Status: Terminated

Product Quantity: 411 kits

Code Information:

F1021035 and F1021036

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated