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Varicella Zoster Virus (VZV) IgG ELISA

DRG Instruments Gesellschaft mit beschränkter Haftung · Model EIA-2808 · UDI-DI 04048474028089

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The Varicella-Zoster Virus (VZV) IgG ELISA test system is intended for the qualitative detection of VZV IgG antibody in human serum. When performed according to these instructions, the results of this test, together with other clinical information, may aid in the determination of immune status, and/or aid in the diagnosis of VZV infections.

Recalls

Date	Firm	Reason
2022-11-09	Biomerieux Inc	As the temperature and time out of range was exceeded, product performances cannot be guaranteed
2019-12-10	bioMerieux, Inc.	Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient's sample result or a valid calibration may lead to a false po
2008-08-27	Calbiotech Inc	The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall,
2003-09-10	Diasorin Inc.	Varicella Zoster ELISA kit assay was producing invalid runs on the ETI-Max 3000 automated microtiter plate instrument and/or false negative results.

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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.