Recall Z-2409-2018 ยท GMD Antisera, Latex Agglutination, Cryptococcus Neoformans
Immuno-Mycologics, Inc
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebral spinal fluid (CSF). The CrAg Lateral Flow Assay is a
| Date | Mar 30, 2018 |
| Status | Terminated |
| Reason | Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results |
| Root cause | Nonconforming Material/Component |
| Action | On March 30, 2018, IMMY issued URGENT MEDICAL DEVICE RECALL notices to their customers via email. The notice instructed customers how to identify a device which may fail. The following are actions to be taken by the customer/user: " You may continue using the affected lots. Any testing performed on defective strips should be considered invalid and should be repeated. " Please immediately notify lab personnel who are running the test to look for defective strips (as seen by fast wicking and/or very weak control lines). " Please immediately complete the attached Acknowledgement and Receipt F |
| Quantity | 875 units |
| Distribution | On March 30, 2018, IMMY began issuing URGENT MEDICAL DEVICE RECALL notices to customers via email. Customers were advised on how to recognize that the device has failed. The following are Actions to be taken by the customer/user: " You may continue using the affected lots. Any testing performed |
| 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 |