Home › IMMUNODIAGNOSTIC SYSTEMS LIMITED › IDS SARS-COV-2 IgG

IDS SARS-COV-2 IgG

IMMUNODIAGNOSTIC SYSTEMS LIMITED · Model IS-ID6502 · UDI-DI 05060169695962

QKO Prescription

510(k) clearances

1,550

Adverse events

Recalls

Facilities

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data 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.