Lyher
Hangzhou Laihe Biotech Co.,Ltd. · Model 303002 · UDI-DI 06972412619405
Description
The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) is a lateral flow immunoassay intended for the qualitative detection of and differentiation of IgG and IgM antibodies to SARS-CoV-2 in serum and plasma (dipotassium-EDTA, lithium-heparin, or sodium-citrate). The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicatingrecent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri |
| 2023-03-09 | Ortho-Clinical Diagnostics, Inc. | Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed |
| 2022-06-24 | LumiraDx | Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA. |
| 2022-06-24 | LumiraDx | Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA. |
| 2022-05-26 | Ortho-Clinical Diagnostics, Inc. | On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU). |
| 2022-04-17 | PROTERIXBIO | FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false positives or false negatives). |
| 2022-01-13 | Lusys Laboratories, Inc. | COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S. |
| 2021-12-22 | Empowered Diagnostics LLC | COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA. |
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed result |
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed result |
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