Recall Z-0545-2022— Immuno-Mycologics, Inc
Class II · Terminated
Class II FDA medical device recall by Immuno-Mycologics, Inc, initiated 2022-01-03, terminated 2024-05-15. It names one FDA 510(k) clearance: K112422. 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..
- Recalling firm
- Immuno-Mycologics, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-01-03
- Terminated
- 2024-05-15
- Firm location
- Norman, OK, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.