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Mutlicode®-RTx HSV 1&2 Kit

LUMINEX CORPORATION · Model 3711 · UDI-DI 00840487101032

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510(k) clearances

Adverse events

Recalls

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Description

The MultiCode®-RTx Herpes Simplex Virus 1 & 2 Kit is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV 1 & 2) DNA in vaginal lesions. It is indicated for use in the detection and typing of HSV-1 or HSV-2 in vaginal lesion swab specimens from symptomatic female patients as an aid in the diagnosis of genital herpes infection.

Recalls

Date	Firm	Reason
2020-05-12	DiaSorin Molecular LLC	Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of 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.