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AccuDiag ™
Diagnostic Automation, Inc. · Model DACD1427-2 · UDI-DI 00850049545259
10
510(k) clearances
135
Adverse events
5
Recalls
31
Facilities
Description
AccuDiag™ Borrelia VlsE1pepC10 IgG/IgM ELISA A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Borrelia burgdorferi in a clinical specimen, using an enzyme immunoassay method.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 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 |
| 2013-02-11 | Innominata Dba Genbio | Multiple incidents of low-reacting assay plates. |
| 2003-10-28 | Biomerieux, Inc. | Kit may contain incorrect components |
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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.