Immuno-Mycologics, Inc Recall 89370
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
Immuno-Mycologics, Inc Recall 89370 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0545-2022 |
| Event ID | 89370 |
| Event 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 Type | Devices |
| 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. |
| Quantity | 411 kits |
| Recall 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. |
| Device Classification | 20220209 |
| Device Code Info | F1021035 and F1021036 |
| Center Classification Date | 20220131 |
| Recall Initiation Date | 20220103 |
| Recalling Firm | Immuno-Mycologics, Inc |
| Initial Notification | |
| Similar To |