Z-0545-2022Class II

CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen...

Name: Z-0545-2022 CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen...
Creator: Immuno-Mycologics, Inc
Published: 2022-01-03
License: https://open.fda.gov/license/

IMMY, Inc. / initiated 2022-01-03 / Terminated / root cause: manufacturing process

FDA source

Immuno-Mycologics, Inc began a recall of CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI... on 2022-01-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0545-2022
Classification: Class II
Status: Terminated
Initiated: 2022-01-03
Posted: 2022-01-31
Terminated: 2024-05-15
Recalling firm: IMMY, Inc.
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
Product code: GMD Antisera, Latex Agglutination, Cryptococcus Neoformans
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Customers who received product were contacted via letter Urgent: Medical Device Recall, Cryptococcal Antigen Lateral Flow Assay, dated January 3, 2022, beginning January 3, 2022, to locate and immediately destroy their affected devices. A recall notification and response form was attached to the email that is to be completed by the customers and returned to the firm.
Quantity in commerce: 411 kits
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.
Product codes and lots: F1021035 and F1021036

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0545-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0545-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-09	2022-01-31

Product code GMD

K112422Class IICrag Lateral Flow Assay (Lfa)Immuno-Mycologics, Inc. / cleared 2012-03-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)