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B. burgdorferi IgG/IgM ELISA

DRG Instruments Gesellschaft mit beschränkter Haftung · Model EIA-2809 · UDI-DI 04048474028096

LSR Prescription

510(k) clearances

135

Adverse events

Recalls

Facilities

Description

The Borrelia burgdorferi IgG/IgM ELISA test system is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG and IgM class antibodies to Borrelia burgdorferi in human serum. This assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme disease

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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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.