Immuno-Mycologics, Inc 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Immuno-Mycologics, Inc
Lot Codes / Batch Numbers
F1021035 and F1021036
Products Sold
F1021035 and F1021036
Immuno-Mycologics, Inc is recalling CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal due to The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to have reduced specificity (90% now versus 9. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026