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Alinity
ABBOTT LABORATORIES · Model 06R9030 · UDI-DI 00380740192136
QKO
Prescription
0
510(k) clearances
1,550
Adverse events
31
Recalls
59
Facilities
Description
SARS-CoV-2 IgG Reagent Kit 1000 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.