Recall Z-0545-2022 ยท GMD Antisera, Latex Agglutination, Cryptococcus Neoformans
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
| Date | Jan 3, 2022 |
| Status | Terminated |
| 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. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112422 | CRAG LATERAL FLOW ASSAY (LFA) Immuno-Mycologics, Inc., Mar 28, 2012 |